CN118475304A

CN118475304A - Apparatus and method for positioning, implanting and using stimulation leads

Info

Publication number: CN118475304A
Application number: CN202280086911.3A
Authority: CN
Inventors: 约瑟夫·W·博格斯二世; 阿蒙·翁莎皮戈恩; 马修·G·德博克; 梅雷迪思·J·麦吉; 德温·塞尔; 罗伯特·B·斯特罗瑟; 乔伊·格罗塞克; 纳森·D·克罗斯比
Original assignee: SPR Therapeutics Inc
Current assignee: SPR Therapeutics Inc
Priority date: 2021-11-17
Filing date: 2022-11-17
Publication date: 2024-08-09

Abstract

The present invention shows and describes an introduction device for deploying an electrode into a target tissue region. The introduction device includes an outer sheath that is fixed relative to the housing. The inner sheath is disposed within the outer sheath. The inner sheath is configured to hold an implantable electrode lead. Optionally, an intermediate sheath is provided between the outer sheath and the inner sheath. The actuator is at least biasingly engaged with the inner sheath. Wherein upon actuation of the actuator, the inner sheath deploys toward the tissue target region.

Description

Apparatus and method for positioning, implanting and using stimulation leads

Cross Reference to Related Applications

The present application claims priority from U.S. patent application No.63/280,413, entitled "Apparatus and Method for Positioning, IMPLANTING AND Using a Stimulation Lead (apparatus and method for locating, implanting and using stimulation leads)" filed on month 11, 2021, and from U.S. patent application No.63,416,732, entitled "Methods for Placement of PERIPHERAL NERVE Stimulation Lead (method for placement of peripheral nerve stimulation leads)" filed on month 10, 2022.

Technical Field

The present disclosure relates generally to locating target tissue and deployment leads, and more particularly, to systems, apparatuses, and methods for locating target tissue regions and deployment leads via a single handheld device.

Background

Electrical stimulation systems have been used to relieve chronic and acute pain and many other medical uses. External devices and implantable devices exist for providing electrical stimulation to activate nerves and/or muscles to provide therapeutic treatments. These "neurostimulators" are capable of providing treatment and/or therapy to various parts of the body. The operation of these devices typically involves the use of one or more electrodes placed on the outer surface of the skin or surgically implanted leads with one or more electrodes. In many cases, surface electrodes, cuff electrodes, paddle electrodes, or epidural or cylindrical electrodes and/or leads may be used to deliver electrical stimulation to selected portions of the patient's body.

In some systems, the electrodes may be inserted percutaneously into the body. In these systems, the electrode or electrodes may be operably positioned on a lead that is percutaneously inserted into the patient. There is a need for several device improvements relating to the positioning and deployment capabilities of electrode leads for various medical capabilities, including electrical stimulation systems.

As widely described in the literature, existing systems and devices for peripheral nerve stimulation may not meet the needs of clinicians and patients. Existing systems may be inefficient; time consuming; and too invasive. They may also require a very extensive training and skill to use; exhibit (or cause) poor device performance/failure and suboptimal efficacy/effectiveness/safety; and is prevented from being used in patients and clinical environments that may benefit from electrical stimulation. In view of these shortcomings, there is a great and unmet need for devices, systems, and methods that allow for safe, effective, reliable, easy to use, and minimally invasive delivery of electrical stimulation leads to treat pain and other conditions.

Some conventional systems for electrode deployment or implantation include two entirely separate procedures and devices-a first test needle followed by a second introducer/electrical lead. These systems with two separate steps can be inefficient, time consuming, and unsuitable for patients because they may require two separate needle insertions. Further, the clinician also reports the need to see which direction the lead anchor of the electrode is facing once the introducer has been inserted into the patient's tissue. Such viewing capability may facilitate efficient deployment of the leads and increase the efficiency of the process. These systems rely on carrying the guidewire within a single needle and deploying the needle by expelling the guidewire out of the open end of the needle. The ability to adjust the positioning of the leads (even in small amounts) is quite limited due to the relatively fragile nature of the leads themselves.

Another system is described in U.S. patent publication No. 2007/0255368. Here, the coiled wire is placed at its desired position via a small diameter needle. The lead is carried in the needle and it has tines or sutures made of a non-conductive material that expand after the lead is deployed outside the needle. The tines/sutures secure the lead in its desired position, but repositioning of the lead during insertion of the process device is difficult, if not impossible, due to the positioning of the lead in the needle and its non-conductive nature. Further, movement or removal of the lead after its deployment will result in tissue damage and destruction.

Furthermore, existing systems may require at least two hands (if not two clinicians) to deploy the lead. Some existing systems require the clinician to hold the viewing device (fluoroscope or ultrasound) with one hand and use the other hand to operate the lead deployment device. One potential problem is that the clinician may be required to release the lead deployment device. This may result in the deployed lead being moved from its applicable position.

In view of the foregoing, there is a need for an improved system for electrode deployment or implantation that allows for test stimulation and repositioning of leads during positioning.

Disclosure of Invention

A number of different interrelated aspects of the invention are described. Features of any particular embodiment disclosed or illustrated herein may be applied to other embodiments and additional features and aspects of the system may be appreciated by those skilled in the art.

A lead introducer system is provided. In one embodiment, the lead introducer system may include one or more (or all): a housing; an outer sheath fixed relative to the housing; an intermediate sheath positioned in the outer sheath and movable relative thereto; an inner sheath configured to hold the lead, the inner sheath positioned in and movable relative to the intermediate sheath and the outer sheath; an actuator in biased engagement with the intermediate sheath and the inner sheath, wherein upon actuation, the inner sheath and the lead are deployed into tissue.

In one embodiment, upon actuation, the inner sheath and lead may move in a distal direction. In one embodiment, upon actuation, the inner sheath and the intermediate sheath may retract in a proximal direction. In one embodiment, movement of the inner sheath and the lead in the distal direction and retraction of the inner sheath and the intermediate sheath occur sequentially. In one embodiment, retraction of the inner sheath and intermediate sheath may occur automatically after the inner sheath and guidewire are moved in the distal direction. In one embodiment, the lead may be configured to anchor in tissue as it moves in the distal direction and to remain positioned in the correct location as the inner sheath and intermediate sheath are withdrawn. In one embodiment, the housing may include one or more handles. In one embodiment, the lead introducer system may be operated with one hand.

A lead introducer system is provided. In one embodiment, the lead introducer system may include one or more (or all): a housing configured to be held by a single hand of a user; an outer sheath fixed relative to the housing; an inner sheath configured to hold the lead, the inner sheath engaged with the outer sheath to move within the outer sheath; an actuator in biased engagement with the inner sheath, wherein upon actuation of the actuator, the inner sheath moves toward and away from the target tissue region.

In one embodiment, the lead introducer system may further comprise an intermediate sheath, wherein the inner sheath may nest within the intermediate sheath and the intermediate sheath may nest within the outer sheath. In one embodiment, upon actuation, the inner sheath and the lead may move together in a distal direction. In one embodiment, upon actuation, the inner sheath and the intermediate sheath may retract together in a proximal direction. In one embodiment, the lead introducer system may further comprise a test electrode insertable into the target tissue region, wherein the lead may be positioned at the exact location of the test electrode by actuation of the introducer system. In one embodiment, actuation of the lead introducer system may include deploying the inner sheath and lead into the target tissue region, anchoring the lead into the target tissue region, and automatically withdrawing the inner sheath from the anchored lead in a single actuation. In one embodiment, the actuator may be a sliding button.

In one aspect of the invention, the introducer system has any combination of the following features:

A housing;

An outer sheath fixed relative to the housing;

An intermediate sheath positioned in the outer sheath and movable relative thereto;

an inner sheath configured to hold the lead, the inner sheath positioned in and movable relative to the intermediate sheath and the outer sheath;

An actuator in biased engagement with the intermediate sheath and the inner sheath, wherein the inner sheath and the lead are deployed into tissue upon actuation.

Upon actuation, the inner sheath and lead may move in a distal direction.

Upon actuation, the inner sheath and the intermediate sheath may retract in a proximal direction.

Movement of the inner sheath and the lead in the distal direction and retraction of the inner sheath and the intermediate sheath occurs sequentially.

Retraction of the inner sheath and intermediate sheath occurs automatically after movement of the inner sheath and guidewire in the distal direction.

The lead is configured to anchor in tissue as it moves in the distal direction and to remain positioned in the correct location as the inner sheath and intermediate sheath are withdrawn.

The housing includes one or more handles.

The lead introducer system may be operated with one hand.

a housing configured to be held by a single hand of a user;

An outer sheath fixed relative to the housing;

An inner sheath configured to hold a lead, the inner sheath engaged with the outer sheath to move within the outer sheath;

An actuator in biased engagement with the inner sheath, wherein upon actuation of the actuator, the inner sheath moves toward and away from the target tissue region.

An intermediate sheath, wherein the inner sheath is nestable within the intermediate sheath, and the intermediate sheath is nestable within the outer sheath.

Upon actuation, the inner sheath and the lead may move together in a distal direction.

Upon actuation, the inner sheath and the intermediate sheath may retract together in the proximal direction.

A test electrode insertable into the target tissue region, wherein the lead can be positioned at the exact location of the test electrode by actuation of the introducer system.

Actuation of the lead introducer system includes deploying the inner sheath and lead into the target tissue region, anchoring the lead into the target tissue region, and automatically withdrawing the inner sheath from the anchored lead in a single actuation.

The actuator is a sliding button.

The introducer system may include an electrical stimulation generator, an open coil-like stimulation lead having an electrically conductive distal anchor and a proximal end in communication with the stimulation generator, and a needle assembly comprising: a first needle comprising an outer sheath having an outer circumference and defining a bore, wherein the outer circumference is discontinuous; a second needle carried within the bore during positioning and testing of the open coil stimulation lead; and at least one test electrode positioned along the outer circumference and in electrical communication with the stimulus generator. The introducer system may further include a third needle including a third needle sheath having a third needle outer circumference and defining a third needle aperture, wherein the open coil-like stimulation lead is carried within the third needle sheath, whereby the open coil-like stimulation lead and the third needle sheath provide for deployment of the open coil-like stimulation lead in place of the second needle.

Additional embodiments and combinations of features are set forth in the claims, all of which are incorporated herein by reference. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of alternatives and/or additions, which are not specifically shown in the appended claims, is used to advantage.

Although individual aspects of the invention are described above, certain features and limitations associated with one aspect may be combined with features and limitations of another aspect. Further, the functions and acts associated with the method aspects may further inform the structural features of the apparatus aspects noted herein. Any of these foregoing features may form the basis of the following claims for further aspects of the invention, even though all of those aspects may not be separately recited herein.

Drawings

The operation of the invention may be better understood by reference to the detailed description taken in conjunction with the following drawings. The accompanying drawings are incorporated in and constitute a part of this specification and are included to provide a further understanding of the present disclosure. In the drawings:

FIG. 1A is a perspective view of a lead-in system;

FIG. 1B is a perspective view of a clinician using a lead introduction system;

FIG. 1C is a cross-sectional view of a lead-in system;

FIGS. 1D-1E are top views of a lead-in system;

FIG. 1F is a cross-sectional view of the lead-in system in a ready-to-deploy position;

FIG. 1G is a cross-sectional view of a lead-in system in a deployed state;

FIG. 1H is a cross-sectional view of a lead-in system in an active deployed state;

FIG. 2A is a partial cross-sectional view of an lead-in system with undeployed leads according to the aspects;

FIGS. 2B-2E are partial cross-sectional views of an introduction system while a lead is being deployed, in accordance with aspects;

fig. 2F includes a partial cross-sectional view (i.e., side view, front view, and top view relative to the first set of images) of the lead wire as it is being deployed along an orthogonal axis;

FIGS. 3A and 3B are cross-sectional side views of an introducer needle having a plurality of test electrodes positioned about an outer surface of an outer sheath;

FIG. 3C is a combination of side and axial cross-sectional views of an introducer needle having a series of slits to provide test stimulation through the electrode itself; the system according to the described aspects, wherein the inner sheath has a first bevel level and the outer sheath has a second bevel level;

FIG. 4 is a cross-sectional view of an introducer system having an outer sheath with a groove formed in an inner surface in accordance with aspects described;

FIG. 5 is a perspective view of an introducer system having an inner sheath and an outer sheath in a windowed configuration in accordance with aspects described;

FIGS. 6, 7A and 8 are views of an introduction system showing an alternative delivery mechanism in accordance with the described aspects;

FIG. 9A is a perspective view of multiple ramps of a sheath in accordance with the described aspects;

FIG. 9B is a perspective and cross-sectional view of a modification of the outer sheath that minimizes the overall profile of the needle/distal electrode combination in accordance with the described aspects;

FIG. 9C is a perspective view of an embodiment in which a distal section of an electrode is secured to a sheath in accordance with aspects described;

FIG. 9D is a top view and a cross-sectional side view of an embodiment of a distal section of an electrode secured to a sheath in accordance with aspects described;

FIG. 10 is a perspective view of an introduction system within a ramped member of an inner sheath in accordance with aspects described;

FIG. 11 is a perspective view of a proximal end of an outer sheath of an introduction system in accordance with aspects described;

fig. 12A and 12B are perspective views of certain embodiments of connections between leads and lead connectors in accordance with the described aspects;

FIG. 13 is a perspective view of certain embodiments of ergonomic features of an introducer system in accordance with the described aspects;

14A-14E are views of certain embodiments for a transport mechanism in accordance with the described aspects;

15A and 15B illustrate a spacer mechanism in accordance with the described aspects;

FIGS. 16A-16C illustrate exemplary stimulation patterns useful in accordance with the described aspects;

FIG. 17 illustrates types of graphical user interfaces that may be included in accordance with aspects described;

FIGS. 18A and 18B illustrate a method in which the stimulation intensity may be adjusted in accordance with the described aspects;

FIG. 19 is a cross-sectional side view of two separate prior art needles;

FIG. 20A is a cross-sectional side view, FIG. 20B is a partial cut-away perspective view, and FIG. 20C is a full perspective view of a needle having a fully rounded face to accommodate an electrode in accordance with the described aspects;

fig. 21A and 21B illustrate an exemplary embodiment of an insulation displacement connector in accordance with the described aspects;

FIGS. 22A-22D illustrate a number of different configurations for quick-disconnect features contemplated in accordance with the described aspects;

FIG. 23 is a perspective view of a bandage system according to aspects described;

24A-24F illustrate how a bandage system according to the described aspects may be applied or replaced; and

Fig. 25A-25C are schematic illustrations of quick-disconnect features contemplated in accordance with the described aspects.

Fig. 26 is a perspective view of a three-part introducer system including a lead connector according to some aspects of the invention.

Fig. 27A-27C are plan views of portions of a percutaneous cannula, stimulation probe, and introducer needle in accordance with certain aspects of the present teachings.

Fig. 28A is a comparative plan view showing the probe combination in the cannula above and the needle combination in the cannula below, while fig. 28B is an exploded plan view of the insert D from fig. 28A.

Fig. 29A-29C are a perspective view and a close-up cutaway plan view (as shown in an enlarged quadrilateral cross-section) of a percutaneous cannula, a stimulation probe, and an open cannula portion of an introducer needle, respectively, in accordance with certain aspects of the present teachings. In fig. 29B and 29C, only a cross-sectional view of the probe and needle (including the outer position of the distal anchor) is provided on the rightmost edge.

Fig. 30 is a perspective view of an exemplary embodiment of a needle of the introducer system of this disclosure.

Fig. 31 is a close-up perspective view of the exemplary embodiment of the needle of fig. 30.

FIG. 32 illustrates one embodiment of a needle or cannula having indicia for communicating depth and "pass/fail" criteria to facilitate lead placement that may be used in an introduction system;

33A-33B are cross-sectional views of an embodiment of an introduction system at a transition stage of undeployment, deployment, and ease of lead placement;

FIG. 34 is a perspective view of an embodiment of an introduction system having a sliding actuation mechanism to facilitate lead placement;

FIG. 35 is a view of an embodiment of the intake system as shown in FIG. 33 with a portion of the housing removed to provide a view of the internal components and mechanisms;

FIG. 36 is a perspective view of an embodiment of an lead-in system having a sliding actuation mechanism and a visual housing window to facilitate lead placement;

FIG. 37 is a schematic diagram illustrating various positions of a forward-most or distal-most portion of an embodiment of an introduction system, wherein a cannula may desirably be capable of being disposed in multiple stages A-D to facilitate lead placement;

FIG. 38 is a schematic diagram of an embodiment of a process using an infusion system, showing how an exemplary infusion system may desirably require a minimum number of steps to allow placement, testing of stimulation and deployment of leads at a target location;

FIG. 39 is a perspective view of an embodiment of an introduction system having a push button actuation mechanism to facilitate lead placement and a portion of the housing removed to provide a view of the internal components and mechanisms;

FIGS. 40A-40C are exploded perspective views of an embodiment of an introduction system having a rotary actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

FIG. 41 is a perspective view of an embodiment of an insertion system having a sliding actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

FIG. 42 is a perspective view of an embodiment of an introduction system having a sliding actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

FIG. 43 is a perspective view of an embodiment of an introduction system having a sliding actuation mechanism to facilitate lead placement and including one or more gripping portions;

44A-44D are cross-sectional and exploded views of an embodiment of an introduction system having a sliding actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

45A-45B are cross-sectional and exploded views of an embodiment of an introduction system having a living hinge actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

FIG. 46 is a cross-sectional and exploded view of an embodiment of an introduction system having an actuation mechanism to facilitate lead placement, and a portion of the housing is shown transparent to provide a view of the internal components and mechanisms;

fig. 47 is a cross-sectional view of the upper arm of a patient with lead placement according to the present teachings.

Fig. 48 is a cross-sectional view of a lead placed between the fascia lata and the ilium to the target femoral nerve.

Fig. 49 is a cross-sectional view of a lead placed on a target sciatic nerve.

Fig. 50 is a schematic view of a lead inserted in a non-intercepted trajectory through a nerve.

Fig. 51 is a schematic view of a lead having a small surface area facing the nerve (e.g., the end of the lead) inserted toward the nerve and a lead having a longer length/larger surface area facing the nerve inserted through the nerve. The lines emanating from the leads represent the stimulation current.

Detailed Description

Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. It is to be understood that other embodiments may be utilized and structural and functional changes may be made without departing from the corresponding scope of the present invention. In addition, features of the various embodiments may be combined or altered without departing from the scope of the invention. As such, the following description is given by way of illustration only and should not be taken as limiting in any way the various alternatives and modifications that may be made to the illustrated embodiments and that remain within the spirit and scope of the invention.

Any element described herein as a singular can be plural (i.e., anything described as "a" or "an" can be more than one). Any lower element of the upper element may have the characteristics or elements of any other lower element of the upper element. The described constructions, elements or complete components and methods and variations thereof for performing the elements of the invention and aspects of the invention may be combined and modified with each other in any combination. As used herein, the words "example" and "exemplary" mean an instance or illustration. The word "example" or "exemplary" does not indicate a critical or preferred aspect or embodiment. The word "or" is intended to be inclusive rather than exclusive, unless the context indicates otherwise. As one example, the expression "A employs B or C" includes any inclusive combination (e.g., A employs B; A employs C; or A employs B and C). As another aspect, the articles "a" and "an" are generally intended to mean "one or more" unless the context indicates otherwise.

Described herein are systems, apparatuses, and methods that may conveniently provide and/or facilitate implantation of a single deployment device to contain a lead. The leads (also referred to as micro-leads, thin wire leads or simply electrodes) may be of generally smaller diameter than prior systems, and optimally sized less than 1.0mm, and more preferably less than 0.65mm. Further, the electrodes may have a generally coil-like or helical configuration rather than a smooth cylinder. However, the present teachings are not limited to this configuration of leads. Any suitable configuration may be employed without departing from the present teachings. In one aspect, embodiments described herein may advantageously provide a single device that can locate a desired tissue region, test stimulation of the tissue region, locate (or reposition) a test signal, and/or deploy an electrode or lead. Exemplary embodiments may allow repositioning of the device and lead within human or animal tissue without deploying the electrode or lead until its deployment is desired by a user (e.g., a clinician). Embodiments may provide systems, devices, and/or methods that are easy to use and secure.

For clarity, the term "proximal" in the context of the present application generally refers to the end of an electrode that is not inserted into the body, and "distal" generally refers to the end of an electrode that is inserted into the body near the nerve. Depending on the manufacture of the electrode structure, the proximal end may be wrapped in an insulating or protective coating or cladding. To the extent that electrical connection must be made to the proximal end, the components involved will allow for the removal of such coatings/cladding. The coating/cladding may include indicia that serve as a marker of mobility that helps gauge whether repositioning or displacement of the electrode has occurred during use of the system and particularly when outside of the supervision of the clinician.

As used herein, the terms inner sheath, introducer needle, inner probe, introducing member, and/or the like are used interchangeably unless the context indicates otherwise or is worth specifically distinguishing between these terms. The terms outer sheath, delivery needle, outer probe, outer member, and/or the like are used interchangeably unless the context indicates otherwise or is worth specific distinction between these terms.

The introduction device may allow the lead to be placed percutaneously a safe distance from the surgical site, which may increase safety, minimize risk to anatomical structures that are the focus of the procedure, minimize risk of infection, and minimize the potential impact of any infection in the circumstances where it may occur. As one non-limiting example, the device may allow placement of the lead to deliver stimulation to a nerve innervating an area that may be painful or expected to be painful due to surgery (e.g., the device may allow placement of the lead to deliver stimulation to a femoral nerve, a sciatic nerve, or a lumbar nerve plexus innervating an area such as a knee where a knee replacement surgery may be being performed), and the device desirably allows placement of the lead a safe distance from a surgical site (e.g., the knee) (e.g., in the upper thigh, upper leg, or lower back) and/or outside of the surgical site.

The introduction device may allow the target nerve to be determined prior to lead placement and prior to lead deployment as part of a non-surgical procedure.

The introduction device may be used with a device that delivers therapeutic electrical stimulation (e.g., peripheral Nerve Stimulation (PNS)) to a nerve (e.g., peripheral nerve) innervating a pain area to provide pain relief. The device may deliver stimulation to nerves that deliver pain signals, or it may deliver stimulation to nerves that do not deliver pain signals, but when the stimulation is delivered, the condition or symptom (such as pain) may be relieved or improved and/or the function may be improved or restored. The device may deliver pain relief or functional recovery peripheral nerve stimulation in the following cases: in a number of different environments, including chronic, acute, post-operative, post-traumatic, and intermittent pain and/or loss of function and other conditions (e.g., other types of pain and/or loss of function); and spans a range of anatomical regions including, but not limited to, extremities (e.g., arms, legs, etc.), extremities (e.g., hands, feet, fingers, toes, etc.), joints (e.g., hips, knees, shoulders, elbows, ankles, wrists, etc.), back, neck, head, face, and other regions.

The device may allow delivery of electrical stimulation immediately following surgery to provide pain relief or functional improvement. The device may allow for the delivery of stimulation before, during and after surgery, as well as in situations where surgery is not involved, such as acute or chronic conditions within or outside the surgical setting.

Additional embodiments of an introducer system according to the present teachings are described below. In the description, all of the details and components may not be fully described or shown. Rather, the primary features or components are described, and in some cases differences from the above-described embodiments may be pointed out. In addition, it should be understood that these additional embodiments may include elements or components that are employed in the above-described embodiments but which are not illustrated or described. Thus, the description of these additional embodiments is merely exemplary and is not intended to be all-inclusive or exclusive. In addition, it is to be understood that the features, components, elements, and functions of the various embodiments may be combined or altered to achieve a desired transcutaneous stimulation system without departing from the spirit and scope of the invention.

The described invention may reduce lead placement and testing procedure duration when placing one or more self-anchoring leads that are used with an electro-stimulation device to treat pain. In particular, placement and testing time is reduced as compared to prior art systems by reducing the number of percutaneous insertions required (e.g., insertion of a needle for test stimulation and a separate needle for lead deployment, or a system in which multiple percutaneous needles/tubes/catheters are inserted to increase the size of the percutaneous access and allow the leads to be inserted). Thus, in contrast to prior systems that required multiple insertions and/or separate leads to deliver stimulation, the present system allows for greater steerability of the introducer system, particularly along its axial length (i.e., the depth to which the needle is inserted and repositioned without deploying the lead anchor). Furthermore, while some prior systems rely on self-anchored leads made from flexible coils with distal anchors electrically and mechanically integrated within the electrodes, the present system marks a further improvement in the fracture resistance of the flexible helical coils, namely by protecting them from stress and metal fatigue during the insertion process (plus the anti-migration and anti-infective qualities of such flexible coil-like or helical structures).

Non-limiting examples of the present system include an introduction and testing system that reduces the number of percutaneous insertions required and/or allows the goals of introduction, testing, and/or lead deployment to be achieved with a minimum number of insertions (e.g., as few as one (single) insertion). In particular, stimulation testing and lead insertion/deployment may both be incorporated into one system, which may require as little as one (single) percutaneous insertion, injection or placement. The invention described herein eliminates these problems while still allowing for deployment of an anti-migration coiled lead with a distal anchor.

The introduction device may include an outer sheath or a delivery sheath. An inner sheath, stylet, or introduction member may be disposed within the outer sheath. In some embodiments, the introduction system may further include an intermediate sheath positioned between the outer sheath or delivery sheath and the inner sheath, the intermediate sheath positioned in the outer sheath and the inner sheath positioned in the intermediate sheath. The inner sheath may be configured to engage and/or manipulate the implantable electrode. In one example, the delivery sheath/intermediate sheath may include a stimulation probe having an uninsulated portion at or adjacent the distal end of the delivery sheath/intermediate sheath, as applicable. The outer sheath/intermediate sheath may be coupled to a power source or stimulation signal that generates a circuit at the proximal end. The clinician may control the application of the stimulation signal to the tissue region via the outer sheath/intermediate sheath. The clinician may needle a tissue region to apply a stimulation signal and observe a response (e.g., neural response, muscle response, etc.) or lack of response to the stimulation signal. When the clinician observes a desired response at a target tissue region (e.g., a region where the desired response is observed), the clinician may facilitate deployment of the electrode. For example, the clinician may press, twist, or otherwise manipulate a mechanical/hydraulic/electrical mechanism (or other suitable mechanism) to translate the intermediate sheath and/or the inner sheath and electrode lead relative to the distal end of the outer sheath. When the anchor region of the electrode (e.g., the terminal portion having a bend, barb, hook, etc.) is at least partially deployed, the introduction system can retract the inner sheath, outer sheath, and/or intermediate sheath while the electrode remains in or near the desired tissue region. The anchor region may be uninsulated to allow the stimulation signal to be delivered. In another aspect, the electrode may include a micro-lead or insulating region that may extend from the anchor region and may be connected to a stimulus source. It should be noted that the stimulus source may be wearable, implantable, or of various other suitable types, such as those disclosed in U.S. patent publication No.20150073496A1, which is incorporated by reference in its entirety.

A lead-in system 2000 is shown in fig. 1A-1H. The lead introduction system 2000 may be used with the leads described herein or the embodiments described in any of fig. 2-51, which are incorporated herein by reference. It should be noted that any descriptions related to the various embodiments described herein, such as systems 2000, 100, 1000, 1200, etc., and components related thereto, may be isolated and adapted from each other, such as systems 2000, 100, 1000, 1200, etc., and components related thereto, without limitation. The lead introduction system 2000 is configured to allow a clinician to deploy the lead 2090 in a safe and efficient manner while requiring only a single hand.

The lead-in system 2000 may include a housing 2004 that encapsulates the internal components of the lead-in system 2000. The housing 2004 may be formed of any material including, but not limited to, plastic, metal, or rubber materials. In some embodiments, the housing 2004 may comprise a medical grade plastic, such as polycarbonate, which in one example may be sterilized. The housing 2004 may be formed by any known process, such as molding, injection molding, extrusion, and the like. Forming the housing 2004 by injection molding is an effective and efficient way of forming the housing 2004 because it contains certain internal features.

The lead-in system 2000 may include a back cover 2008. The rear cover 2008 may be integrally formed with the housing 2004 or may be a separate component that is attached to the housing 2004 in a later operation (such as by fastening, welding, friction fit, etc.).

An outer sheath 2012 may extend from the housing 2004. The outer jacket 2012 may extend from the aperture 2016 in the housing 2004. The outer jacket 2012 may be formed of any suitable material including, but not limited to, metal, plastic, or rubber. In the illustrated embodiment, the outer sheath 2012 is formed of a medical grade metal. As shown in fig. 1C, the outer jacket 2012 may extend from a bore 2016 at a center point of the bottom portion 2020 of the housing 2004.

The outer jacket 2012 may extend into the inner portion 2024 of the housing 2004 and may be held in place within the inner portion 2024. In the illustrated embodiment, the proximal portion 2028 of the outer sheath 2012 can be engaged with a sheath carrier 2032 of any suitable configuration. The jacket bracket 2032 may fit within the interior portion 2028 of the housing 2004 adjacent the bottom portion 2020. The sheath carrier 2032 may include an aperture 2036 positioned near the center point, whereby the outer sheath 2012 extends through the aperture. In one embodiment, the outer jacket 2012 may be connected to a jacket bracket 2032. In one embodiment, the sheath carrier 2032 may be overmolded onto the outer sheath 2012. The sheath bracket 2032 can include one cutout 2040 or a plurality (e.g., two or more) cutouts 2040. The cutout 2040 may be of any configuration and may serve to reduce the amount of material of the sheath carrier 2032, which helps reduce the weight of the sheath carrier 2032 while maintaining its strength and integrity. In some embodiments, cutout 2040 may not be present.

The lead-in system 2000 may further include a biasing member 2044. The biasing member 2044 may be attached at one end to the sheath bracket 2032. In one embodiment, the sheath bracket 2032 may include a recess 2048 to which the biasing member 2044 is secured. Further, as shown, the biasing member 2044 may include a coil spring. Although a coil spring is shown, the biasing member 2044 is not limited to this configuration. The biasing member 2044 may comprise a resilient material, a leaf spring, a piston arrangement, or the like.

The second side of the biasing member 2044 may be connected to a needle carrier 2052, which will be described in more detail below. The biasing member 2044 is configured to bias the needle carrier 2052 relative to the sheath carrier 2032, as will be described in more detail below.

The lead-in system 2000 further may include a resilient pin 2056. The resilient pin 2056 may be configured to receive an end of the outer sheath 2012 to secure the outer sheath 2012 in a fixed position relative to the housing 2004, which prevents movement of the outer sheath 2012 relative to the housing 2004.

The elastic pin 2056 may receive a needle 2060 that is generally aligned with the outer sheath 2012 such that the lead 2090 may extend through the needle and into the outer sheath 2012. A second end of the needle 2060 may be engaged with the needle carrier 2052. The biasing member 2044 may surround the needle 2060, and as described above, the biasing member 2044 is attached to the needle carrier 2052.

The lead introduction system 2000 may include an introducer bracket 2064. The introducer bracket 2064 may be movable relative to the sheath bracket 2032. In the illustrated embodiment, the biasing member 2044 can bias the introducer bracket 2064 relative to the sheath bracket 2032 as the biasing member 2044 is biased. The biasing member 2044 may be compressed upon actuation of an actuation mechanism (such as a slider), which in turn may be actuated by a manual force (e.g., a physician's hand).

The lead-in system 2000 can include a second biasing member 2068 in which a first end thereof is engaged with the needle carrier 2052. A second end of the second biasing member 2068 may be engaged with the introducer carrier 2072. The introducer carrier 2072 may be engaged with the intermediate sheath 2076. The introducer carrier 2072 surrounds the intermediate sheath 2076 such that the intermediate sheath 2076 is free to move relative to the introducer carrier 2072.

The lead-in system 2000 may include an actuator 2080 of any suitable configuration. As shown in fig. 1A-1H, the actuator 2080 may include a slide 2084. The slide 2084 may include a thumb or finger engagement portion 2088. The thumb or finger engagement portion 2088 may be configured to allow a user's thumb or finger to engage to aid in engaging and operating the slider 2084.

The lead introduction system 2000 may further include a barrel cam 2092. The barrel cam 2092 is engaged with the actuator 2080 and the introducer carrier 2072 such that an opening actuation of the actuator 2080 will rotate the barrel cam 2092. The barrel cam 2092 includes a ramp portion 2096 that engages the introducer carrier 2072. As the barrel cam 2092 rotates, the introducer carrier 2072 will follow the ramp portion 2096 to move the introducer carrier 2072 toward the sheath carrier 2032. As the introducer carrier 2072 moves toward the sheath carrier 2032, it will compress the second biasing member 2068 toward the sheath carrier 2032, placing the second biasing member 2068 in a compressed state.

As the introducer carrier 2072 moves up the ramp portion 2096, the intermediate sheath 2016 moves out of the outer sheath 2012, see fig. 1F. The second biasing member 2068 (or biasing member 2044 in some embodiments) can be used to deploy the lead 2090 forward with the inner sheath 2108, and the inner sheath 2108 inserts the lead 2090 into the body tissue at a predetermined location (e.g., a location that provides optimal or preferred stimulation to the target tissue). As the introducer carrier 2072 continues to move up the ramp portion 2096, the inner sheath 2108 is removed from the intermediate sheath 2016 and the outer sheath 2012 and the lead is positioned at the desired location in the tissue. As the introducer carrier 2072 continues to move upward along the ramp portion 2096, it will eventually fall off of the ramp portion 2096. When the introducer carrier 2072 falls off the ramp portion, the second biasing member 2068 will become uncompressed and bias the inner sheath 2108 and the intermediate sheath 2016 into the outer sheath 2012 (which may be fixed or likewise movable with the inner sheath 2108 and the intermediate sheath 2016). Further, the needle carrier 2052 will be biased toward the barrel cam 2092, which releases the inner sheath 2108 and the intermediate sheath 2016 into the outer sheath 2012.

Lead introduction system 2000 can include introducer 2100. Introducer 2100 is configured to hold and support lead 2090 for deployment of lead 2090 from lead introduction system 2000 through inner sheath 2018. Introducer 2100 generally includes a tubular member that houses lead 2090. The introducer 2100 is operably coupled with the inner sheath 2018 such that a lead can pass from the introducer 2100 through the inner sheath 2018 and then into the target tissue during deployment. In some embodiments, introducer 2100 may be part of inner sheath 2018.

At the end portion of introducer 2100 is a back cap 2008. The rear cover 2008 may be formed of substantially the same material as the housing 2004. In some embodiments, the rear cover 2008 may form a portion of the housing 2004 so as to have an appearance integrally formed with the housing 2004. In other embodiments, the rear cover 2008 may be integrally formed with the housing 2004. Rear cover 2008 forms a rear stop for lead-in system 2000. The rear cover 2008 prevents the leads 2090, the intermediate sheath 2016, and the inner sheath 2108 from falling out of the rear of the housing 2004.

In operation, the lead introduction system 2000 allows a clinician to use a single-handed operation. The housing 2004 of the lead introduction system 2000 is configured to be held in one hand by a clinician. To this end, the housing 2004 may include any suitable configuration of gripping portions 2112. As shown, the grip portion 2112 may include a vertical groove in the housing 2004. However, the gripping portion 2112 may be of any configuration, such as a knob, knurl, horizontal groove, slot, tab, or the like. The grip portion 2112 may be positioned on the housing to assist the clinician in gripping the lead-introduction system 2000 with a single hand and may even assist the clinician in gripping the lead-introduction system 2000 when there is lubricant on the clinician's hand.

Once the clinician holds the lead-introduction system 2000, he or she may position it so that the lead 2090 may be deployed in a predetermined location. Once this position is reached, the clinician may actuate the actuator 2080. This may begin deployment of lead 2090. In the illustrated embodiment, when the actuator 2080 is actuated, the lead-in system 2000 will operate as described above. This will cause the lead 2090 to be deployed into a predetermined tissue location while allowing the intermediate sheath 2076 and introducer 2100 inserted into the patient's tissue to be withdrawn while leaving the lead 2090 in place. The clinician then need only slide the remainder of the lead 2090 out of the lead introduction system 2000 and connect the lead 2090 to the lead connector.

In some embodiments, introducer 2100 may include a test electrode or multiple test electrodes, the operation of which is described below. In these embodiments, lead introduction system 2000 may include lead connector 2116. The lead connector 2116 may be a configuration that operatively and electrically couples an external pulse generator (or an implantable pulse generator in some embodiments). To test and confirm the position of lead 2090, the clinician may operatively and electrically connect lead connector 2116 to the pulse generator. The clinician may then send out an electrical stimulation signal from the pulser through the lead connector 2116 to one or more test electrodes that may be positioned on the outer sheath 2012 and/or the intermediate sheath 2016. This may then help the clinician determine if lead 2090 is to be deployed in the proper location for stimulation therapy. Once the clinician determines that the location is appropriate, the clinician may begin deployment of the lead 2090 as described above.

Turning now to fig. 2A-2E, one embodiment of a lead-in system 100 is shown with particular emphasis on how the leads are deployed. Although the same system is shown in each of these figures, certain reference elements are omitted in certain views in an effort to highlight particular aspects of the views shown in the figures. In particular, in the illustrated figures, the outer sheath 2012 is not shown, but will define the outer sheath 150. The introduction device 100 includes an inner sheath 102, an implantable electrode 130, and an outer sheath 150. The outer sheath 150 may include a hollow tube or needle having an outer sheath cavity 154. In one embodiment, outer sheath 150 may be a 19 gauge needle with an inner diameter of about 0.5-1.0mm and an outer diameter of about 0.8-1.20mm. In one embodiment, the outer sheath 150 may have an inner diameter of about 0.85mm and an outer diameter of about 1.03 mm. The outer sheath 150 may be between about 100-150mm in length. In one embodiment, the outer sheath 150 may have a length of about 125 mm.

The outer sheath 150 may be constructed of an echogenic (i.e., highly visible under ultrasound conditions) material to facilitate use of the system 100. Such materials include, but are not necessarily limited to, polymers, metals, stainless steel, or combinations of two or more materials. Additionally or alternatively, the shape of the outer sheath itself may be configured to be effectively echogenic. Still further, only certain portions of the introducer system (including but not necessarily limited to the outer sheath) may have echogenic features (by material or construction/shape).

The inner sheath 102 is disposed within the outer sheath 150 so as to allow it to extend from the cavity 154, as shown and described below in fig. 2A-2E. The inner sheath includes an inner sheath cavity 104. In one embodiment, the inner sheath 102 may be a 21 gauge needle with an inner diameter of about 0.5-0.9mm and an outer diameter of about 0.7-1.10mm. In one embodiment, the inner sheath 102 may have an inner diameter of about 0.61mm and an outer diameter of about 0.8 mm.

The inner sheath 102 comprises any suitable material including, but not limited to, a polymer, a metal, stainless steel, or a combination of two or more materials. The implantable electrode 130 is disposed at least partially within the cavity 104 and along a portion of the interior of the inner sheath 102 so as to allow the electrode 130 to move freely relative to the inner surface. In an alternative embodiment described in detail below, the electrode 130 has a coil-like structure with a centrally disposed axial void space that can receive a stylet that serves as a deployment mechanism and/or structural support prior to deployment of the electrode 130. In this alternative embodiment, the stylet engages the electrode along the axial void of the electrode, but again allows independent movement of the stylet relative to the electrode under certain conditions.

The implantable electrode 130 can include a micro-lead 138 disposed within at least the interior of the outer sheath 150. The electrode 130 itself is deployed through the cavity 104. Micro-leads 138 may extend from distal lead anchor 134 and be coupled (e.g., removably or non-removably) to a stimulation signal generator (not shown). The lead anchor 134 may include an uninsulated portion of the electrode 130, which may be curved, hooked, barbed, or the like. As such, lead anchor 134 can deliver stimulation signals during and after it is positioned and deployed. Further, the electrode 130 (including the lead 138 and the anchor 134) may have any combination of the following features on some or all of the components: a monopolar nature; a helical and/or open coil-like structure having a central void capable of receiving a stylet; and/or multiple strands of conductive material are wound together and electrically parallel with respect to each other.

While the particular disclosure of implantable electrode 130 contemplates subcomponents including micro-leads 138 and anchors 134, the more general term "lead" may refer to a stimulation device from its distal anchor up to its proximal connection to the stimulation generation unit, including portions that may be sheathed, covered, or coated with an insulating material. In contrast, the generic term "electrode" may refer to an exposed conductive portion of a lead that is inserted into the body to deliver a stimulus.

As shown in fig. 2A and 2B, the lead anchor 134 may include a curved or hooked portion such that a portion of the lead anchor may wrap around or hook over the distal end 108 of the inner sheath 102. When the lead anchor 134 is not deployed, a portion of the lead anchor 134 may be disposed in the region 120 between the inner sheath 102 and the outer sheath 150. The lead anchor 134 may be composed of any suitable material including, but not limited to, a polymer, a metal, stainless steel, or two or more thereof or a combination. In one aspect, the lead anchor 134 may be electrically and mechanically integral with the electrode (through which the stimulus is delivered).

Fig. 2B-2E illustrate the relative movement of the inner sheath 102 and the outer sheath 150. After insertion (fig. 2B and panel (a) of fig. 2E), these elements move in coordination with each other. To deploy the electrode 130, the relative movement of one of the sheaths is inhibited or reversed, thereby extending the electrode out of the cavity 154. Once the inner sheath 102 extends far enough out of the cavity 154 (fig. 2D and panel (D) of fig. 2E), the distal anchor 134 is released from the region 120 and embeds itself in tissue adjacent the introducer system 100. The inner sheath and outer sheath are retracted (together or separately) and the electrodes are thereby released (e.g., temporarily separating the electrodes from the pulser, sliding the sheath away, physically removing the sheath, etc.). As seen in fig. 2F and as will be described in more detail below, deployment may also involve rotational movement (indicated by arrows) that allows the anchor to be released and extend through the passage or slit of the sheath.

The outer sheath 150 has an inner diameter that is sufficiently larger than the outer diameter of the inner sheath 102 to establish the region 120 where a portion of the lead anchor 134 is disposed prior to deployment of the electrode 130. The distal end 158 of the outer sheath 150 may be uninsulated and the body 162 of the outer sheath 150 may be insulated to allow current to be delivered to the distal end 158 without the body 162 of the outer sheath 150 directly stimulating tissue. It should be noted that the area of uninsulated distal end 158 may be approximately equal to the area of the uninsulated portion of lead anchor (e.g., electrode) 134 to ensure an equivalent test of stimulation on the targeted tissue region.

The present invention includes a lead insertion/deployment system and the test stimulation system may be combined into a single system where electrodes (incorporated into the needle) are employed to deliver the test stimulation current. In various non-limiting examples, the external portions of the system are insulated or non-conductive except for one or more portions, which are uninsulated and conductive to serve as stimulus test electrode contacts. The stimulation test electrode contacts may be mechanically integrated with the outer needle and the electrode contacts are suitably positioned, such as at a location that provides information to guide the proper/optimal positioning of the lead prior to deployment of the lead.

The characteristics of the electrode contacts may be designed to represent, predict, or otherwise provide information regarding the performance of the lead prior to lead deployment, particularly with respect to size, shape, material, and surface area. For example, by selecting mechanical and/or electrical characteristics (e.g., similar impedance, contact material such as stainless steel, and/or similar surface area such as 10mm ²) that are similar to or representative of the lead electrode contacts, the characteristics of the test electrode contacts will be representative of the expected performance of the lead. The test electrode location should be at or adjacent the distal end (or tip) of the introducer needle such that when the self-anchored lead is deployed, the lead remains in close proximity to the location occupied by the test stimulation electrode. Alternatively, the plurality of electrode contacts may advantageously be spaced along the needle/sheath (e.g., 1mm-30mm spacing, preferably 1 mm) such that test stimulus can be delivered on the same needle from one or more different test electrode contacts, allowing the optimal location for the stimulus to be determined while minimizing or eliminating the need to move and reposition the lead-in system during the test stimulus/optimal location identification process. In this multiple test electrode configuration, test stimulation is delivered from multiple locations from one percutaneous insertion to determine the optimal deployment location for self-anchored, anti-infective, and anti-migrating coiled leads with distal anchors/electrodes.

In one embodiment, the lead anchor 134 may be folded over the inner sheath 102, such as at the distal end 108 of the inner sheath 102, so that the lead anchor 134 may be received in the region 120 between the inner sheath 102 and the outer sheath 150 prior to deployment of the lead anchor, such as during testing and/or positioning of a target tissue region. Such accommodation of lead anchor 134 may allow repositioning of delivery locations and testing of tissue irritation prior to deployment of lead anchor 134, as well as other potential uses.

Test stimulation for lead deployment may be achieved by transmitting electrical current into surrounding tissue through a needle and/or sheath or a test electrode located on an outer surface thereof. The test electrodes may be formed via openings in an insulating polymer jacket positioned around the outer sheath 150 (or in some embodiments, the inner sheath 102) and the current is transmitted through the sheath itself for stimulation, or the electrodes may be discretely formed elements (possibly including discrete wiring for stimulation signals). Other configurations are also contemplated that use a conductive coating (in appropriate contact with the pulser/signal source) disposed along selected outer surfaces of one or both of the sheaths. Alternatively, the test stimulus may be implemented by an exposed portion of the electrode 130 itself. In this configuration, a portion of the distal end of the lead protrudes through the lumen 154 (and in some embodiments, the lumen 104), while the lead itself remains in an undeployed state (i.e., in some embodiments, the anchor portion 134 is still securely held within the region 120). In either instance, after insertion of the introducer device 100 into tissue, the test stimulus is delivered before the lead is deployed and anchored in the tissue.

In fig. 3A and 3B, the exposed outer portion or portions of the needle 150 include a plurality of test electrodes 152. The test electrodes 152 may be positioned at intervals along the length of the needle and/or at different locations radially around the circumference of the needle. Although some embodiments may include only a single test electrode, the use of multiple electrodes is advantageous because it allows test stimulation to be achieved at multiple locations in tissue with as few (e.g., a single) needle insertions and/or injections and/or movements as possible, thereby ensuring that the procedure is simple and time efficient while avoiding the need to reposition the introducer or lead to assess other potential electrode locations. While an outer sheath 150 is shown, the inner sheath (if used) may contain similar test electrodes. In this configuration, it should be appreciated that the inner sheath must be sufficiently expelled through the cavity 154 in order to expose the test electrode 152 to tissue intended to receive the test stimulus, but in this configuration the inner sheath should not be expelled too far outside the outer sheath so that the anchoring system 134 becomes embedded in the tissue. The electrodes 152 may be positioned at regular or irregular intervals along a straight linear line or around some or all of the circumference of the needle. Although multiple electrodes are shown, some embodiments may require only a single test electrode. Furthermore, while the electrodes are shown as extending along the length of the needle, it may be possible to position the electrodes at different locations around the circumference, or even use full circumferential electrodes at one or more locations.

In another embodiment, the electrodes (e.g., analog electrodes surrounded by insulating material or conductive electrodes on the surface of the needle and/or sheath) may be repositionable (e.g., by a pull or twist control mechanism in the needle hub or handle) and may be used for test stimulation at multiple locations, providing the advantage that multiple locations of test stimulation may be applied in a single insertion without deploying leads. In another embodiment, a coating (e.g., insulating, polymeric) may be applied locally or globally to any surface (e.g., conductive, metallic) in contact with the lead and/or an external needle (e.g., the interior of an inner needle or an outer needle, the exterior of an inner needle) in order to prevent the release of current from undesired locations and allow the proper stimulation to be used to determine the location for lead deployment.

In all embodiments, a lubricious coating (e.g., a hydrophobic coating such as polytetrafluoroethylene) and/or a biocompatible lubricant (e.g., a silicon-based material) lubricant is applied along any portion of the needle and/or along other moving portions within the system 100 to enhance the ease of manipulation of the introducer component (e.g., sheath and/or needle) as directed by the clinician. This configuration enables ease of movement and helps to avoid the need for a larger diameter in the design of the introducer, as well as minimizing the risk of improper movement of the needle (which may damage the lead), and improves the ease of the lead placement process to eliminate the possibility of technical difficulties for the clinician.

In fig. 3C (which is rotated compared to the views shown in fig. 2A-3B in order to eliminate the view of the edge of the distal end of the needle), a slit 160 is provided along the length of the outer needle 150. While shown extending along the underside of sheath 150 up to tip 154 of sheath 150, it should be understood that channel 160 may be formed in a line or pattern along only a portion of sheath 150, or it may include a series of slits, channels, or apertures to accommodate a lead anchor (not shown in fig. 3C) as described herein. Further, the channels, slits, or apertures may be formed along any axis of the sheath, and are not limited to only the top or bottom side. An optional test electrode 152 may also be positioned adjacent to the fracture to facilitate positioning of the introducer system. After appropriate test stimulation and positioning, the electrodes are rotated relative to the outer sheath 150 to allow anchors (not shown) to be released and deployed into the tissue. The clinician will ensure that the deployment corresponds to the best test electrode 152 as determined during the test stimulation procedure.

In one aspect, for example, the introduction device 100 may be designed to include two needles with minimal increase in size for a single needle design. As shown in fig. 4, the outer sheath 150 may have a groove 156 along at least a portion of its inner surface 158, thereby forming a space for a lead anchor (not shown in fig. 4). This design may allow the lead anchor 134 to fit and/or translate into the groove 156. In one aspect, the groove 156 may allow the diameter of the outer sheath 150 to be smaller because additional space (e.g., region 120) for the lead anchor 134 is reduced.

In an embodiment as shown in fig. 5, the diameter of the sheath may be reduced by having a slit 110 in the inner sheath 102 so that the lead anchor 134 may re-enter the inner sheath 102 after its deployment, allowing the outer sheath 150 to be positioned adjacent to the inner sheath 102 or even in direct contact with the inner sheath 102. The distal end 108 of the inner sheath 102, including the slit 110 and the lead anchor 134 extending beyond the inner sheath 102 and reentering the slit 110, may be located outside of the outer sheath 150 such that the remainder of the inner sheath 150 may remain in direct or near direct contact with the outer sheath 150. Further, the inner sheath 102 may be composed of any suitable material including, but not limited to, thin-walled polymers, metals, stainless steel, or combinations thereof. The thinner material for the inner sheath 102 may allow the outer sheath 150 to have a smaller diameter and still accommodate the inner sheath 102 or a portion thereof.

The application of test stimulus (e.g., stimulus performed prior to or during lead deployment and/or repositioning) that represents stimulus performed by the lead itself is advantageous because it allows the clinician to quickly and easily determine the desired location for lead deployment with a minimum number of needle insertions, thereby avoiding the need for repositioning the needle and/or lead. Minimizing needle insertion minimizes risk and discomfort to the patient and generally provides a more reliable method for lead deployment than prior systems.

Although shown as having a tapered edge similar to the edge of the outer sheath 150, the distal end of the inner sheath 102 need not be cylindrical; but rather it may be of any suitable size and shape. For example, the distal end 108 may be beveled, cylindrical, partially cylindrical, notched, rectangular, or the like.

In one embodiment as shown in fig. 6, the function of the inner sheath 602 may be implemented/substituted by a shaft having curved arms or end portions 656. The bent end may be locked across the inner sheath lumen 504 to retain the bent anchor of the lead 634. When ready for deployment, the inner sheath 602 may be pushed forward, engaging the anchor 634 in place or otherwise disposing the anchor 634 in tissue. The inner sheath 602 may be rotated to the side and retracted into the inner sheath cavity 504. The flex arms 656 may then rest along the inner wall of the inner sheath 602 or may be otherwise positioned to allow the inner sheath 602 to be retracted while retaining the deployed anchors 634 in place.

The lead insertion/deployment system and the test stimulation system may be combined into a single system, with the lead deployment mechanism housed within a single sheath/needle/tube housing the lead. This example may include a stylet that extends through and/or with the lead within the introducer needle/sheath. As seen in fig. 7, stylet 170 may provide increased stiffness to the flexible coiled lead, allowing the lead to be maneuvered within the needle. In this example, the anchor of the lead may be fully contained within the introducer needle and/or secured such that the system may be repositioned without deploying the anchor until such time as deployment of the lead and anchor is desired. The release mechanism may engage the electrode/lead along one or any number of points and is accessible to the clinician to allow selective retraction of the stylet 170 after the system 100 is properly positioned.

The stylet system solves the problem of selectively deploying self-anchored leads, thereby creating a selective self-anchored lead deployment system having significant advantages over the prior art, including designs and/or fabrication that have design advantages such as anti-infective, anti-migration, anti-fracture, selective self-anchoring mechanisms, etc., anchors integrated with the electrode contacts such that stimulation can be delivered through the anchors (further ensuring that proper positioning of the contacts is maintained as needed), allowing the leads to remain in a desired location within the tissue while being used for treatment and/or testing/testing, and then allowing easy, safe, comfortable, and/or reliable extraction/removal as needed. While the stylet or core may be used in embodiments having a single sheath/needle/tube, it may also be used with a multiple sheath system, where one or more sheaths are used to contain/secure the leads and/or to deliver test stimuli, and the stylet/core is used to position/deploy the self-anchoring leads in an optimal position. Non-limiting examples of methods for lead and/or anchor deployment are described in other sections.

In another embodiment, the lead and/or electrode anchor may be held in place (e.g., within one of the needle and/or sheath) by a balloon (e.g., inflatable and/or deflatable or expandable and/or compressible substance or device), whereby manipulation (e.g., inflation, deflation, compression) allows the lead to be released, exposed, and/or deployed (e.g., exposure of the lead anchor, release of the outer sheath needle, allowing it to be retracted and the lead to be deployed). The use of a balloon is advantageous because it prevents premature movement of the lead, sheath, and/or needle, stabilizes the lead and/or anchor to protect the lead or tip from damage, and can allow the electrode lead anchor to be fully deployed (e.g., into surrounding tissue) to secure the lead and prevent movement of the lead (e.g., after deployment of the needle or during withdrawal of the needle).

Further, as a non-limiting example, the uninsulated lead ends may be manufactured or bent into the shape of an anchor, but loaded into a needle and held in a straight posture as seen in fig. 8. In this case, the lead end anchor 134 will be designed and manufactured to return to its original shape during lead deployment. When exposed by retraction of the outer needle 150 or advancement of the inner sheath or stylet 170 (as indicated by the respective arrows in fig. 8), the lead ends can be bent to anchor into the nearby tissue.

The straight lead ends may also be pushed by a balloon or sheath or pulled into an anchoring position by a hook (e.g., bent). In alternative embodiments, the leads may be composed of, coated with, or framed with a shape memory alloy (e.g., nitinol) that returns to a desired shape upon exposure to a change in temperature or heat of the human body. The wire breakage rate may also be reduced by eliminating the need to store the wire in a bent end, which would eliminate excessive forces on the wire end anchor during storage and wire placement.

Once testing has determined the desired location for placement of the lead anchor 134, the inner sheath 102 can be pushed forward relative to the distal end 158 of the outer sheath 150. In one aspect, the inner sheath 102 may be pushed forward until the lead anchor 134 is exposed. The inner sheath 102 and the outer sheath 150 can be slid relative to one another to expose a portion or all of the lead anchor 134. In one embodiment, the lead anchor 134 may be moved approximately 0.1-0.3mm from its initial position. In one embodiment, the lead anchor 134 may be moved about 0.2mm from its initial position. In one aspect, the outer sheath 150 can be pulled/retracted back until the lead anchor 134 is exposed. This aspect requires that the lead anchor 134 remain stationary throughout the placement process, i.e., in the same position relative to the targeted tissue (e.g., nerve or nerve fiber) and non-targeted tissue. Once the lead anchor 134 is exposed from the inner sheath 102 and/or the outer sheath 150, the micro-leads 138 can be deployed and/or anchored to the targeted tissue area. Further, the inner sheath 102 and outer sheath 150 can also be slid to re-cover the lead anchor 134 and/or micro-leads 138 in order to reposition the leads closer to or further from a target tissue region, such as a nerve. In one embodiment, leads 134 may be exposed without deployment. In one embodiment, leads 134 may be initially exposed without deployment and then may be deployed at a later stage. In one embodiment, the leads 134 may be repositioned multiple times.

It may be clinically advantageous to limit the difference in position between the final lead deployment site and the test stimulation site such that the clinical outcome of the stimulation with the final deployment lead in place is substantially equivalent to the stimulation outcome during the test stimulation at the optimal location. In at least one embodiment, the distal end 158 of the outer sheath 150 can include a substantially different bevel (e.g., a deeper bevel or a greater angle of bevel) than the bevel of the distal end 108 of the inner sheath 102. This may allow the lead anchor 134 to be deployed without pushing the inner sheath 102 beyond the end of the outer sheath 150. The bevel of the distal end 158 of the outer sheath 150 and the bevel of the distal end 108 of the inner sheath 102 may be inclined in directly or partially opposite directions. This particular configuration may limit how far the inner sheath 102 must be manipulated (e.g., pushed, etc.) to allow deployment of the lead anchor 134. In one embodiment, the bevel of the outer sheath 150 may be shallower or at a smaller angle than the bevel of the inner sheath 102.

The present invention includes a system that combines test stimulus and lead insertion/deployment into a single system. One non-limiting example (where the lead insertion/deployment system and the test stimulation system may be combined into a single system) is one such non-limiting example where self-anchoring leads are employed to deliver test stimulation current prior to being selectively deployed at an optimal location as determined by the test stimulation. In this example, the self-anchoring lead includes one or more anchors on the distal portion of the lead that are also active/electrode portions of the lead (e.g., stimulation current is delivered through the anchor portion of the lead) that allow the test stimulus delivered through the lead (and thus through the lead anchor) to be optimally similar to the final stimulus when the self-anchoring lead has been deployed, as the anchor itself securing the lead in place in the tissue is delivering the stimulus. This example may include a lead anchor/active electrode portion that is fixed relative to the insertion needle such that all or a portion of the uninsulated portion of the lead (e.g., the electrode/anchor through which current is delivered to the target tissue) is exposed to the stimulated target tissue. In this example, the anchors of the lead may be fixed so that the system may be repositioned without deploying the anchors until such time as deployment of the lead and anchors is desired.

In summary, the fixation of the leads can be implemented by the following features: a sheath that secures a terminal (i.e., distal) end of the anchor while leaving a portion of the lead (e.g., a bend of the anchor) exposed to tissue; a sheath or sheath that secures the lead anchor and can be opened/broken to deploy the lead anchor; and/or the end of the lead is received within the insertion needle and a portion of the anchor (e.g., the bend of the anchor) extends beyond the proximal side of the needle bevel. These examples provide a system that delivers test stimulus within the same system used for lead introduction/deployment, thereby eliminating the need for a separate system, while still allowing the leads to be positioned/repositioned as needed until final deployment. This embodiment may be effectively combined with other portions of the invention described herein so that the goals of lead-in, test, and/or lead deployment can be achieved with a minimum number of insertions (e.g., as few as one (single) insertion).

The introduction device may allow multiple or additional lead locations or potential lead locations to be tested and evaluated prior to deployment of the lead. In one aspect, the introduction device may allow the introducer to be advanced, withdrawn, or otherwise repositioned (e.g., moved forward or backward or in other directions) without deploying the lead. The introduction device may allow for systems and methods for advancing, retracting, or otherwise repositioning (e.g., in any 3-dimensional tissue volume) the selective self-anchoring lead. One non-limiting example of a non-selectively self-anchored lead (e.g., a lead that is self-anchored, but not selectively self-anchored) may include a lead having a distal electrode that may be mechanically and electrically integrated with a distal anchoring mechanism.

In the prior art, the non-selective self-anchoring lead will typically undergo unwanted deployment retraction or repositioning of the introducer. That is, if the non-selective self-anchoring lead and introducer system is advanced beyond an optimal position (e.g., undesirably far, too close to the target nerve or structure, etc.), the non-selective self-anchoring lead will still be deployed in a suboptimal position because the lead will self-anchor and self-deploy as the introducer is withdrawn. Previously, non-selective self-anchoring leads and delivery systems could not be retracted, withdrawn, or otherwise moved back without lead deployment. The present introduction devices allow for the use of selective self-anchoring leads and delivery systems, including associated devices and techniques.

The introduction device includes a selective self-anchoring lead and an insertion system that can be positioned at an optimal location for deploying the lead. In this way, the lead is deployed only when needed, and it can be easily and/or atraumatically withdrawn when needed (e.g., when pain relief or functional recovery is no longer needed).

The introduction device provides a re-directable or steerable introducer and lead system. Prior devices do not teach a technique that can be steered in one direction without deploying a self-anchoring lead, and then redirected and steered in another (i.e., different) direction. The introduction device enables one to direct the selectively self-anchored lead and the introducer system and redirect the lead and the introducer system in multiple directions without deploying the lead.

The introduction device may also allow and facilitate the use of imaging guides, such as ultrasound guides and/or fluoroscopic guides, during lead placement, testing, and/or lead repositioning procedures. Visualization of the position, orientation, and/or trajectory of the introducer and/or lead is critical to the clinician's success in placing the lead.

Manufacturing the introducer system, and in particular the outer sheath 150 and/or the lead 130, to include easily visualized/defined indicia simplifies the lead placement process, reduces patient risk, improves lead placement reliability, and avoids improper or premature deployment of self-anchoring leads. The distal end of the lead and/or other sections or lengths of the lead may be fabricated (e.g., coated, marked, textured, etc.) with alternative materials that are easily detected under medical imaging, as this is important to improve ease of lead placement and with imaging detection devices. As one non-limiting example, the lead ends or portions or sections of the leads may be textured to increase the echo intensity, thereby improving visibility under ultrasound. In another embodiment, tightly coiled and twisted structures of multi-stranded lead wires may be braided, coiled or woven at the ends to increase reflectivity and echo intensity. Further, texturing or adding textured conductive coatings to smooth metal will allow for better detection under ultrasound while allowing for electrical stimulation. In another embodiment, the lead ends may be textured to increase the echogenic strength, but coated with a conductive material, which results in a smooth surface that reduces the likelihood of tissue damage, patient discomfort, and allows for easier removal from tissue. Alternatively, in another non-limiting example, a length of the needle or tip may be coated, textured or marked to enhance visibility under ultrasound. Modifying the tip to increase the intensity of the echoes (which increases the surface area) can also reduce the electrode impedance of the needle tip, allowing selective stimulation of desired neural targets. In another embodiment, two introducer needles or sheaths may be marked, coated or etched in a ribbon pattern to mark the length along the shaft. In such embodiments, bands or markers may be used to assist in deploying the leads at the desired depth, to guide movement of the needle or sheath relative to each other, and to differentiate them under ultrasound imaging and facilitate lead placement. Further, the markings of the sheath or needle may be used as a scale for distance and depth during the lead placement process, which is important for estimating distance and insertion depth from, for example, nearby target or non-target structures. In another embodiment, the introducer needle or sheath may be constructed of a magnetizable material (e.g., ferritic stainless steel or non-metallic magnets) for detection with advanced ultrasonic needle positioning systems.

The position, orientation and/or trajectory of the introducer and/or lead is important for the clinician to successfully place the lead under, for example, x-ray imaging such as fluoroscopy, x-ray or CT. Modifying existing introducer systems and/or leads by adding radiopaque markers can simplify the lead placement process, reduce patient risk, and increase reliability of lead placement, allowing visualization of lead placement and avoiding improper or premature deployment of self-anchored leads. In addition, the lead ends or needles may be coated with a radiopaque or radio-dense substance (e.g., barium, radiopaque polymer) to enhance visibility under x-ray imaging (e.g., fluoroscopy, x-rays, CT). A radio-dense metal, such as platinum, gold, tantalum, or a radio-opaque conductive polymer, for example, may be applied to the lead ends, allowing visualization under x-ray imaging, while still allowing current flow for stimulation. As one non-limiting example, a portion of the lead (including the uninsulated or insulated wire) may be coated or fabricated with radiopaque materials such as titanium, tungsten, barium sulfate, and zirconium oxide to allow for better detection under fluoroscopy or x-rays. This would allow visualization of potential fragments on x-rays to allow for better detection of lead fragments left after removal of the lead. In one embodiment, the coating may be sprayed or electroplated onto the lead ends. In another non-limiting example, a radio-dense marker may also be applied in some bands or sections along the length of the needle and/or the lead for identifying the position and depth of the lead or needle in the tissue under x-ray imaging. In another embodiment, a radiopaque marker along the length of the lead may be used to assess lead depth and track lead migration during treatment, making it easier to confirm lead placement stability for continuous treatment. As another non-limiting example, the inner and/or outer sheaths may be marked or identified with radiopaque material to aid in visualization of lead placement and needle depth under fluoroscopy, monitoring the respective positions of the needles or sheaths, and properly deploying and anchoring the leads.

The introduction device may also implement a selective self-anchoring lead and insertion system that may place the selective self-anchoring lead in a mobile anatomical location (including, but not limited to, extremities, joints, back, neck, head, abdomen, torso, face, and extremities), promote tissue ingrowth sealing the skin exit site, and prevent lead positioning into and out of the skin, which may further minimize infection risk.

The introduction device may also avoid interfering with the normal function, rehabilitation or restoration to normal function of the body or body part. As one non-limiting example, the introduction device may avoid interfering with the use of the joint (e.g., before, during, and/or after a joint repair or replacement procedure) and avoid interfering with the use of the joint (e.g., including the original joint, the prosthetic joint, and/or the replacement joint) during post-operative rehabilitation and daily activities.

Some embodiments may employ different designs to provide different exposures of the leads. In one embodiment, the opening at the distal end of the outer sheath has a beveled or sloped edge, as seen in fig. 9A, such that rotating the outer sheath will uncover or re-cover the exposed anchor leads. This may allow the clinician to expose a portion or all of the anchor lead, such as a portion of a barb or tine. In one embodiment, a stop may be added at a predetermined location to allow for ease of exposure of a portion of the lead without deploying the entire lead. In one embodiment, the clinician may apply a rotating or sliding type mechanism to deploy a portion or all of the lead. In one embodiment, the introduction device may employ a rotational technique to only partially expose the lead without fully deploying it, and the sliding sheath may fully expose and deploy the lead, such as in a channel and/or lock design.

In one embodiment as shown in fig. 10, the inner sheath 802 may include a sloped portion 824 that may facilitate deployment when the sheath 802 is withdrawn. This may change (e.g., reduce) the likelihood that the lead 834 is compressed or otherwise retained within the sheath 802. For example, it may reduce the likelihood that the hooked, fork-like, barb-like portions of the lead will be retained or attached to the inner sheath 802. In another aspect, the sloped portion 824 can alter (e.g., increase) the ability to anchor the lead 834 at a desired location. The use of small diameter self-anchored coiled or helical leads allows the duration of the lead placement and stimulation testing process to be minimized, limits the number of percutaneous insertions required, reduces the risk to the patient, allows the leads to be efficiently positioned and repositioned for stimulation testing and lead deployment, allows the clinician to properly and optimally position and deploy the leads with minimal or no additional training, and reduces the time required to form an electrical connection for testing.

Test stimulation by the introducer system requires that current be passed from the external stimulator to the stimulation electrode and/or lead end. The present invention is novel and advantageous in that it allows the introducer system to be coupled to an external stimulator used by the patient, thereby ensuring that the response achieved during the test stimulus (e.g., in a clinic, hospital, etc.) represents the response that would be expected and/or achieved during the treatment (e.g., typical home use by the patient), and further avoiding the need to reprogram the stimulator between test stimulus and return stimulus.

The introduction device may be removably coupled with the stimulator through the use of a lead connector. The stimulator may be powered by a battery embedded within the stimulator itself or an attached electrode.

The battery may be of any suitable size that allows for continuous delivery of the therapy to provide consistent relief to the user. Further, the stimulator may be wirelessly programmable and controllable. In one embodiment, the stimulator may be wired. In one embodiment, the stimulator and the lead-in device may have a custom wireless interface for the clinician and/or patient.

The present invention includes a design to facilitate testing using leads, one non-limiting example being a connector that can quickly and efficiently electrically connect the proximal end of the lead to an external stimulator via wires in an advantageous manner (e.g., a strong/stable mechanical and/or electrical connection), and which can reduce the duration of the procedure. Being able to easily remove the connector also reduces the procedure time because the prior art after deployment of the lead, the introducer system must be withdrawn over the lead, while the connector will prevent its withdrawal and will have to be removed because the introducer needle/sheath cannot be withdrawn over it without first separating the lead. While simple connectors (e.g., commercial alligator clips) may be used, such connectors may be difficult to use in operating settings with very small diameter coil-like leads. A clinician or staff may have difficulty connecting the tiny ends of the wires to a typical/mechanical electrical connector. One non-limiting example of solving these problems is a custom connector that includes a funnel into which the ends of the leads can be easily inserted. The funnel guides the lead wire into the connector area where the spring loaded teeth, ring or surface can be manipulated by a user via a lever or button to clip onto the lead and establish an electrical connection with the lead. The connector may have wires and an attached plug to enable connection with an external stimulator.

The lead connector may be designed to easily couple to a percutaneous lead. In one non-limiting example, the leads 934 may be inserted into the lead connectors 956 through apertures or slots 952, and the lead cables may be partially or completely passed therethrough. The aperture may include a funnel shape where the lead 934 is inserted to allow easy insertion into the aperture, as shown by the arrows in fig. 12A and 12B. In another non-limiting example, the lead connector 956 may be constructed of two or more components with leads placed between and/or within the components, and the components may be secured together (e.g., slid together, snapped into place, twisted/screwed onto each other, etc.) to couple to the leads. In some embodiments, the lead connector may allow for easy one-handed insertion and coupling of leads to the system while remaining mechanically and electrically safe and preventing the patient from intentionally or unintentionally separating the leads (or electrodes).

The leads may be electrically and mechanically coupled to the lead connector. The mechanism by which the leads may be mechanically coupled to the lead connector may be different from or the same as the mechanism by which the leads are electrically coupled to the lead connector. The user may couple the lead to the lead connector using components including, but not limited to, a knob, button, switch, or dial.

The lead connector may be separate from the lead and may allow the lead to be reconnected to the lead connector at different points along the lead (e.g., closer to or further from the lead or the stimulation portion of the electrode). In one non-limiting example, the lead connector may include a lock to prevent the patient from separating the lead. The lock may be opened using, for example, but not limited to, a key, a tool (e.g., a torque wrench), a combination (e.g., a combination), or without a tool. In another non-limiting example, the lead connector may minimize or eliminate damage or changes to the structure of the lead, thereby allowing the lead to remain sufficiently intact to substantially reduce the risk of breakage or breakage of the lead, and allowing current to flow through the entire lead. In another non-limiting example, a lead connector may be attached to the lead either before or after insertion of the introducer system, allowing stimulation through the lead end during the lead placement process. In one embodiment, the connector may be attached to the lead by placing the lead into a slot or hole in the block and closing a flap that enables an insulation-displacement connection (e.g., cutting through the insulation material to one side to form a connection with the conductive lead wire). The lead connector can improve the speed and convenience of lead connection because it can be attached without the use of tools (e.g., a wire-less cutter, scissors, and screwdriver). For example, in this embodiment, the leads may be placed into slots in the lead connector block and secured using a lockable, reversible one-handed mechanism to press through the insulation on the lead body. The insulation-displacement mechanism within the lead connector may also cut the distal leads of the electrical connection. Once the connection has been completed and the excess leads trimmed away, a lock (e.g., slide, twist, button press) can ensure that the cover flap on the block cannot be accidentally reopened. This feature prevents disconnection between the lead connector and the lead, which would result in loss of therapeutic benefit. The lead connector may mate with another lead connector (e.g., a lead or plug to the stimulator) to complete the circuit from the stimulator to the lead end electrode.

In one embodiment, the connection between the two lead connectors may be magnetic. In this case, the shape of the lead connectors will prevent improper alignment of the lead connectors (e.g., the lead connectors that are assembled together in only one orientation). The magnetic connection may be used for temporary and permanent stimulation delivery (e.g., during lead placement procedures or during home use treatment of the patient). After the proper lead placement position is obtained, the lead connector block may be removed and replaced following removal of the introducer system needle and sheath. In one embodiment, the connection may be deactivated by pressing or sliding open a slit that accommodates the lead. In this example, the lead connector block may be removed or cut away before the introducer is removed and then quickly reattached to a more proximal location on the lead. After removal of the introducer, the lead may be placed in the slot and connected (e.g., pressed, slid) with a one-touch mechanism, and then the lead connector may be attached to the stimulator cable.

The magnetic connection may be used as a quick release connection that will prevent accidental lead (or electrode) displacement due to pulling of the lead and/or the lead. Instead of transferring the force to the lead exit site and the lead, any force on the lead will be released due to the disruption of the magnetic connection between the lead and the lead connector block. If desired by the clinician, a permanent connection may be established by locking the two connector pieces together using a push button lock (or any other suitable lock). In addition to mating with the lead connector block, in another embodiment, the magnetic cable connector for the stimulator may also mate with the same version of the lead connector block (which is connected to the test stimulator via a cable). In another embodiment, the magnetic cable connector from the stimulator may be bifurcated to connect with multiple lead connector blocks (e.g., for achieving stimulation of two leads with one stimulator).

The present invention may reduce the discomfort of the lead placement procedure by limiting the diameter of the percutaneous system. Resistance to insertion through skin or tissue skin may result in additional pressure being placed on the patient's skin and/or device, resulting in potential discomfort (e.g., pain or bruise from insertion pressure or from multiple failed pin attempts) and/or strain or damage on the device (e.g., damage to the lead or introducer, failure of the lead deployment mechanism). The reduced resistance to insertion may be achieved by limiting the diameter of the introducer system, designing or making the needle sharper (e.g., sharper heel edge and/or additional bevel), or coating the surface of the needle (e.g., the outer shaft). Modifying the bevel shape or sharpness of the needle in the introducer system (e.g., by adding multiple bevels during needle manufacture or grinding or needle shaping) can make insertion easier (e.g., require less force) and ensure that the lead placement process is more comfortable for the patient. Multiple bevels and increased sharpness of the tip are advantageous because they minimize the risk to the patient, enable reliable insertion, and enable insertion that avoids unnecessary stress on the lead or device. In another embodiment, a coating may be applied partially or completely along the surface of the introducer needle to reduce resistance to insertion through tissue (e.g., a polymer coating that slides more easily through tissue). In one embodiment, the coating may be hydrophobic (e.g., polytetrafluoroethylene, silicone rubber), hydrophilic (e.g., polyvinylpyrrolidone, polyurethane, polyacrylic acid, polyethylene oxide), or liquid impregnated to improve ease of insertion and operability within tissue by reducing friction between the skin or tissue and the needle. Minimizing the insertion force required by the clinician (e.g., allowing the clinician to place the lead) and modifications that do not cause a substantial increase in outer diameter would ensure that selective lead deployment could be performed through a minimally invasive approach, with minimal number of insertions and further minimizing risk and discomfort to the patient.

One way to limit and/or minimize the diameter of the system is by using a needle/sheath and removing a portion along the inner wall of the needle/sheath so that space for the lead anchor is allowed. An example of such a configuration is shown in fig. 9B. The portion of the wall N of the needle/sheath 150 is advantageously removed/thinned so that the lead anchor 134 can be accommodated (e.g., a wall of 1-10mm, preferably 5mm, along the length of the needle from the proximal end of the bevel, and wide enough to allow the anchor to be accommodated (e.g., 0.1-0.5mm, preferably 0.2 mm), but the mechanical strength of the needle is minimally affected, in a system comprising two needles/sheaths, this may also be accomplished by removing a portion of the outer wall of the inner needle (not shown in fig. 9B) in a similar manner, or by doing both so that a portion of the outer needle and a portion of the inner needle wall are removed to form a complete slit for the lead anchor to be received therein.

Another example shown in fig. 9B is the use of a plastic inner tube P that is sufficiently rigid to allow deployment, but flexible enough to enable an outer anchor hook (not shown in perspective) to press into the end of the plastic sheath, allowing the outer needle to be just larger than the inner tube and fully accommodate undeployed leads. The flexible plastic sheath will also have to be flexible enough so that it can be withdrawn over the lead without getting caught. Avoiding having the lead wire hang inside the inner tube would be an important issue in these diameter limiting solutions, where the inner needle may result in little space around the lead wire, which may result in excessive friction. A non-limiting example of a solution to this would be to use a biocompatible lubricant, such as a silicon-based (or other suitable) lubricant, between the application of the parts that must be moved relative to each other.

Referring to fig. 9C and 9D, embodiments of the present invention have a slit or window S milled, cut or otherwise created in the sheath/needle 102 so that the end of the anchor from the anchor lead 134 can re-enter the lumen of the needle/sheath, allowing a second sheath/needle or containment mechanism to be positioned over the portion of the anchor re-entering the lumen of the needle, thereby securing the lead to the testing/introduction system until such time as deployment of the lead is desired. Desirably, this embodiment of the invention can be combined with one or more of the other examples described, including, but not limited to, delivering stimulation through the distal anchor of the self-anchoring lead, and/or using one or more contact electrodes in the outer sheath for delivering test stimulation. Note that in fig. 9C, system 100 is shown in stages of its assembly, with panel (a) showing only the inner sheath, panel (b) showing sheath 150 and lead/anchor 134, and panel (C) showing inner sheath 102, lead anchor 134, and outer sheath 150.

Reducing the outer diameter of the system is desirable because it limits the discomfort experienced by the patient during surgery. In examples where a sheath over the needle is used to secure the lead anchor of the self-anchored coil-like lead in place during placement/testing/repositioning, a tight fit of the outer sheath over the inner needle (which would both limit the outer diameter and better secure the lead anchor) may be achieved by using a sheath material that may shrink, for example, by applying heat or other means that results in shrinkage of the sheath tube diameter. This may also ease the manufacturing and assembly burden of the system, as a tightly fitting sheath will not have to be screwed onto the inner needle and lead anchor. The larger diameter outer sheath can be easily slid into place and then contracted to provide a tight fit.

Desirably, the outer diameter of the system limiting percutaneous or through-the-skin insertion may be implemented to minimize pain and/or discomfort during insertion, stimulation testing, and/or deployment of the self-anchored anti-migration lead, which may preferably be implemented by employing a thin-walled needle or sheath to accommodate the lead during placement/testing/deployment. It is desirable and advantageous to use one or more needles or sheaths of a suitable material (e.g., metal, plastic) having a wall thickness that provides sufficient lumen space for accommodating the leads, minimizes the outer diameter of the system, and provides sufficient resistance to bending and/or other forces to which such a system is subjected during lead placement and testing procedures. The preferred embodiments of the described invention employ one or more thin-walled needles/sheaths, as described in connection with one or more of the examples and embodiments discussed, which also allow the invention to minimize the duration of lead placement and stimulation testing procedures, limit the number of percutaneous insertions required, reduce patient risk, allow efficient positioning and repositioning of leads for stimulation testing and lead deployment, allow a clinician to properly and optimally position and deploy leads with minimal or no additional training, and reduce the time required to form an electrical connection for testing.

A tightly fitting sheath over the needle may pose potential problems for lead deployment, for example the sheath may adhere more strongly to the surface of the needle than intended, such that movement of the sheath over the needle is prevented or such force is required, making the device unsafe or not user friendly, and may additionally cause delays or lengthening of the procedure. One non-limiting example of overcoming this problem is to apply a lubricant between the sheath and the needle so that sliding of the sheath over the needle is enhanced or requires less or minimal force. The lubricant may be based on silica gel, but may also be realized by other suitable materials. Another non-limiting example of a method of overcoming this problem is to have a mechanism by which the sheath can be split. This may be achieved by embedding a thin wire in the sheath, which may be pulled during lead deployment, and which causes the sheath to split allowing the lead anchor to be released. These aspects of the invention may be advantageously combined with the other described embodiments of the invention.

Another embodiment of an aspect of the invention to overcome the potential problem of improper attachment of components to one another is described in a non-limiting example as using a manufacturing method in which a placeholder is used during the manufacture of a plurality of different, tightly fitted components (e.g., such a placeholder, such as a solid metal wire, which is preferably slightly larger than the diameter of a wire used during the manufacture/assembly of a plurality of different components designed as anchors (e.g., outer sheath, with or without a slit or a section removed or ground away, particularly to accommodate wire anchoring)) to secure the wire. This is advantageous because it allows the final parts to fit tightly/securely together, but prevents over-tightening that would impede or prevent deployment and/or positioning and/or testing.

The present invention may prevent/reduce user errors and accidents during lead placement and stimulus testing by allowing single-handed lead placement and deployment. For example, the lead deployment mechanism may be manipulated by one hand such that the other hand is not required to deploy the lead. Such an embodiment is advantageous because it both reduces the difficulty of using the system by the clinician and allows the clinician to use the other (non-deployed) hand for another purpose, such as for manipulating the ultrasound probe during lead deployment, so that the position of the lead can be observed. This may be advantageous because it may be used to re-ensure in real time to the clinician that the distal anchor of the self-anchoring lead remains in the desired position during lead deployment and/or retraction of the test/introduction system. As non-limiting examples, preferred embodiments of the lead deployment mechanism may include a lever, push button, gear, slider, push button, twist knob, handle with gripping surface for pulling or pushing on, co-extruded handle/lever, and/or other means of mechanically and/or electrically actuating the deployment component. Embodiments of the deployment component (e.g., the outer sheath and/or the inner stylet or core) are described in other sections, and one or more of these can be advantageously combined with one or more of the lead deployment mechanisms so that the clinician can easily and effectively control the deployment of the self-anchoring lead. Ideal embodiments of the lead deployment mechanism may enable the mechanism to be activated and/or controlled in a one-handed and/or two-handed manner. The ability to selectively operate with one or both hands may enable the physician to select which mode of operation is preferred as desired. For example, if the use of ultrasound or a steady support or pressure applied to the patient is most beneficial at the time of activation, it may be desirable to activate with one hand. Or in some cases, for some doctors, holding the device steady with both hands while operating the mechanism may achieve extremely accurate deployment of the leads and optimal stability of the device.

In one embodiment of the invention, placement and repositioning of the lead is aided by design elements that enhance controllability or convenience whereby the clinician can handle the system during percutaneous placement, retraction and/or repositioning of the system before, during and/or after stimulation testing and lead deployment. Such an embodiment may limit the procedure time, providing significant benefits to the patient and clinician. One non-limiting example of such an embodiment is the application of ergonomic, gripping, texturing, and/or other tactile features that may be located on the proximal end of the needle/system and/or on the deployment mechanism to facilitate placement of the lead through the skin and tissue of the patient, as seen in fig. 13. Such an embodiment may provide significant benefits to patients with tough or thick skin, as the clinician may otherwise have difficulty applying the necessary pressure to quickly insert the system through the skin at the desired location.

Fig. 14A shows an embodiment of an introduction device 400. In one aspect as shown in fig. 14A, the introduction device 400 includes a proximal end 412 having a body 414 with a lock 416. The body 414 may be composed of any suitable material, including polymers, metals, stainless steel, or a combination of two or more thereof. The locking element 416 may be any suitable type of locking element or stepper including, but not limited to, a lever, trigger, plunger, button, wheel, switch, threaded member, or the like. When engaged, the locking member 416 may prevent the inner sheath from advancing or moving to any degree. This may occur through the use of threaded systems, locks, steppers, etc. By releasing the locking member 416 via pushing, pulling, twisting, or any other suitable mechanism, the inner sheath can be disengaged from the locking member system and can be advanced, for example, out of the outer sheath 450. As the inner sheath advances, the lead may be deployed. The locking member 416 may be composed of any suitable material including polymers, metals, stainless steel, or a combination of two or more thereof. The locking elements 416 may be composed of the same material as the body 414, or they may be composed of a different material. The body 414 includes a ring 418 and a stem 422 configured to engage with a clinician's finger during use. The ring 418 may engage the locking member 416 and, when engaged, may allow the inner sheath to move out of the outer sheath 450.

The stem 422 may be composed of any suitable material, including polymers, metals, stainless steel, or a combination of two or more thereof. The handle 422 may be designed to support the clinician's fingers and thus may be etched or rubberized or comfortable to service to enhance traction and comfort to the user.

In one embodiment, the body 414 may include several rings configured to engage with the clinician's fingers during use, such as the thumb and index and ring fingers, or the thumb, index and middle fingers for different users. In one aspect, the body 414 may not include any rings.

As seen in fig. 14C and 14D, the system, and more specifically the needle 150, is inserted into the target tissue/through the skin. The needle is mechanically fixed to a component X which in turn can be fixed/fastened to the body/skin of the patient, as an example by means of an adhesive Y. The components are secured to the system and the patient's body such that the system is held securely in place relative to the patient until such time as the clinician decides that the system is to be repositioned and/or removed. The components may be connected to the system via any suitable mechanical connection (e.g., clamps, locks, twists, or other securing mechanisms) that may be secured and/or removed with minimal effort and time. In addition, the components may also be connected to the patient's body via any suitable mechanical connection (e.g., adhesive tape, bandages, gels, hydrogels, or other securement mechanisms compatible with temporary use on the skin) that limits patient discomfort and may be secured and/or removed with minimal time and effort. The components may be secured to both the patient and the system such that movement of the system relative to the patient's body is minimized during the test stimulation process and/or lead deployment.

In this non-limiting example, a component (such as the one described above that mechanically mates with the system to introduce/insert the self-anchoring lead and deliver test stimulation to the patient's body) is implemented such that the component can freely rotate relative to the patient's body while locked in place relative to the system until the desired locked position is determined. Alternatively, the component may be locked relative to the patient's body before being locked in the final position, while allowing free rotation/positioning of the system. Such components may also allow the locking/fixing of the position to be released as needed for repositioning or removal of the system.

The component X described above mechanically mates with the system to introduce/insert self-anchoring leads and deliver test stimulation to the patient's body, is implemented such that the component is fixed in position with respect to the patient's body, and contains a mechanism that allows the angle of the lead insertion/stimulation test/lead deployment system to be adjusted and locked in place as needed. Such components may also allow the locking/fixing of the position to be released as needed for repositioning or removal of the system.

The present system includes a design that objectively repositions the percutaneous system. A potential problem with delivering test stimulus via a system in which the anchors of the lead are partially or fully housed is that the lead may be inadvertently deployed, i.e., by moving the inner and/or outer needle in an unintended manner or relative distance and/or other methods of deploying the lead (e.g., the lead advances more than intended or at unintended times). One example of a method of reducing this risk is a system whereby the relative positions of the inner and outer needles (or other deployment mechanisms such as a stylet) can be locked, blocked or revealed during insertion, testing and/or deployment. One embodiment of such a solution is to have a series of stops in the proximal portion of the deployment system that allow the needles to be positioned relative to each other by twisting, pushing, clicking, rolling, sliding, or other control means implemented with a lever, locking mechanism, or other means.

Such non-limiting examples of an embodiment of the present invention (which allows for objective repositioning of the percutaneous system) include mechanical and/or visual markers that show the relative positions of the percutaneous introduction system and the lead and/or stylet and/or inner sheath/positioning mechanism. Such indicia may indicate the position of the lead relative to the position in the introducer (e.g., the distance of the distal end of the lead from the distal end of the introducer sheath) and/or the position of the end of the introduction system in the tissue/body (e.g., the distal end depth of the introducer system and/or the angle relative to the skin at the insertion/access site). Alternative or complementary marking embodiments may include a location of a distinct marking (e.g., marking for deployment, locking, and/or other desired system and/or lead locations). Such an invention may preferably combine these aspects of the embodiments, allowing the depth and angle of the introducer system and lead to be readily discernable relative to each other and/or the skin/insertion site. Such embodiments allow for objective repositioning of the percutaneous system, and may be combined with one or more other examples discussed in this disclosure, such that the duration and difficulty of placing the helical, migration-resistant, and infection-resistant leads in optimal positions is reduced or limited. It may include a plurality of arcuate channels positioned orthogonal to one another. One or more screws, clips, or spring-loaded pins cooperate within the channel (possibly including a slit or other predetermined point along an arc or arcs) to fix the angular position and rotation of the introducer needle relative to the surface of the patient's skin (i.e., the injection site for the needle).

The present invention includes a design that objectively repositions the percutaneous system. A potential problem with delivering test stimulus via a system in which the anchors of the lead are partially or fully housed is that the lead may be inadvertently deployed, i.e., by moving the inner and/or outer needle in an unintended manner or relative distance and/or other methods of deploying the lead (e.g., the lead advances more than intended or at unintended times). One embodiment of such a solution is to have a series of stops in the proximal portion of the deployment system that allow the needles to be positioned relative to each other by twisting, pushing, clicking, rolling, sliding, or other control means implemented with a lever, locking mechanism, or other means. Such an embodiment may allow the lead to be moved into several different positions, such as, but not limited to, a locked/secured position for insertion, a partially deployed position for testing, a retracted position for repositioning, and a deployed position. Such embodiments allow for objective repositioning of the percutaneous system, and may be combined with one or more other examples discussed in this disclosure, such that the duration and difficulty of placing the helical, migration-resistant, and infection-resistant leads in optimal positions is reduced or limited.

In the non-limiting example of concentric needles or sheaths, a mechanism is needed to control movement of the needle and sheath relative to each other and surrounding tissue to ensure proper positioning of the lead deployment and to avoid damage to the lead. Selective lead deployment may be achieved by sliding the outer needle to expose the bevel of the inner needle and the end of the lead and retracting the needle to position the lead end or anchor into the nearby tissue. However, in this non-limiting example, the device used to control the distance the needle moves is critical to accurate lead placement and to ensure that the needles do not move or slide relative to each other before or after deployment of the lead to prevent shearing, breaking or bending the lead or the lead tip.

To achieve such level control, a spacer or a position maintaining mechanism S as shown in fig. 15A and 15B may be used. These spacers lock the two needles together during insertion through the skin by the clinician and then allow the lead to be deployed at the desired location. In one embodiment, the spacer may be comprised of a partial or complete cylinder and is located between the hubs of the inner and outer needles. In such embodiments, the spacer may be removable, with threads on the ends that allow the spacer to be locked to the hub of each needle (e.g., the spacer may be removed by twisting the spacer through the threads on the needle hub and sliding the spacer off). In another embodiment, the spacer may be held in place and deflated to allow retraction of the outer needle. For example, in this embodiment, twisting or pressing a button on the spacer (as indicated by the arrow) will allow the spacer to be shortened, allowing directional retraction of the outer needle.

In another non-limiting example, the needle hub of the outer needle or the inner needle may be withdrawn into the handle of the introducer a particular distance. In another non-limiting example, the components of the introducer handle can be twisted to retract any of the needle, sheath, or guidewire a particular distance. This will allow for controlled retraction of the needle and proper placement of the lead. In one embodiment, the handle used to control retraction and movement of the needle may be ergonomically designed to fit the clinician's hand in a smooth profile and to enable one-handed operation of the introducer system with a push button or slider. One-handed operation will further enable proper lead placement, for example, allowing the clinician to visualize the target with ultrasound with one hand while advancing, retracting or repositioning the introducer system, and then deploy the lead with one hand. In addition, the handle of the introducer may be marked to show the direction or side of the needle where the lead is to be deployed to further assist the clinician in proper placement of the lead.

In one non-limiting example of an introducer with multiple stimulation electrodes, the entire system or components may be retracted to the desired position for effective test stimulation, the outer needle retracted and the lead tip deployed. Here, the leads may be deployed at any location along the length of the external test needle without having to redirect the needle. A slit or opening along the length of the outer needle (also described above) will allow the lead to be repositioned without having to move the outer needle. In this embodiment, the lead may be repositioned with an inner sheath or needle that allows the lead to be repositioned within the needle and then deployed at any depth along the needle.

One non-limiting example is an embodiment in which multiple contacts may be positioned on the introducer at specific intervals such that only one needle insertion and one repositioning of the insertion/testing system may be required prior to lead deployment. In one non-limiting example, the contacts are spaced apart (e.g., 1 mm) (+/-) on the outer pin. The needle may be inserted to a distance of Ymm mm (e.g., 5 mm) from the nerve. The test stimulus may be delivered from each contact individually or in combination, as desired or needed, for example, starting with the most distal contact. If stimulation at the Z-th (e.g., 4-th) contact provides the best response, the clinician may retract the introducer system Z millimeters (e.g., 4 mm) and deploy the lead (with or without retesting, either or both of which may be desirable in a number of different situations, potentially facilitating the provision of options to the clinician).

In another non-limiting example, there may be software to accelerate, expedite, or automate the process, including the process of delivering test stimuli at multiple contacts in sequence. In one non-limiting example, once information such as calibration points or ranges (e.g., ranges of physiological responses to stimulation intensities, ranges of distances from targeted or non-targeted tissue, etc.) is known from testing the first (or other) contact, the software may allow the test to be progressively faster or more rapid for subsequent contacts. It may be advantageous not to fully automate it (e.g. to ensure that the stimulus does not produce unwanted reactions such as pain, discomfort, or unwanted muscle contractions).

The present invention may prevent/reduce user errors and accidents during lead placement and stimulation testing by automatically incorporating patient feedback during stimulation testing via patient controlled testing systems, simplified parametric testing procedures, and/or systems that require only patient feedback to operate. This may advantageously reduce the time of the testing process and/or may limit the number of position changes that the system requires before the optimal or desired lead deployment location is found.

One non-limiting example of incorporating patient feedback into a stimulation test is one in which the test stimulus is controlled by the patient. A controller (e.g., a hand-held remote control, tablet, smart phone, or other suitable interface) is handled by the patient, which may have the ability to deliver stimulation current directly to the test stimulation system via a cable, or may control the stimulation generator via wired and/or wireless technology (e.g., bluetooth, radio frequency). Further, the generator is mechanically and/or electrically connected to the test stimulation system such that an electrical stimulation current may be delivered to the target tissue through the system. The patient controller may allow the patient to adjust one or more parameters (e.g., pulse width, amplitude, frequency, and/or waveform of the current/signal/test stimulus) so that the patient is able to obtain a desired physiological response (e.g., paresthesia, muscle contraction, and/or pain relief). Alternatively, such a controller may be processed by a clinician and adjustments made based on the results of the test stimulus (e.g., based on verbal feedback from the patient, visualization of the contraction directly and/or via ultrasound, and/or clinical experience). The non-limiting examples described herein may be advantageously combined with one or more of the examples/embodiments of the described invention.

Where the stimulation test is patient controlled, one aspect of the present invention (reducing the overall procedure duration) may be hampered by complex stimulation test controls and/or parameters and/or provide the patient (or clinician) with more options than necessary to test and determine the optimal or desired lead deployment location. These risks can be minimized by simplifying the method and/or control for adjusting the parameters during the stimulus test. Fig. 16 shows several parameters (i.e., pulse width and amplitude of the stimulus) and how these parameters are adjusted by the patient controller. As represented by the straight line arrows in each of panels (a) through (c) of fig. 16, there are only a limited number of inputs/buttons/knobs/controls (e.g., 1 through 5 functional features, and more preferably 3). These inputs correspond to the ability to increase and/or decrease the parameters as shown in fig. 16. In one embodiment, a single button increases one or more parameters (e.g., pulse duration, amplitude, frequency, and/or combination of parameters), another button decreases one or more parameters, and a third button allows the test stimulus to be turned on and off. The control may advantageously be calibrated or designed specifically for a given type or style of stimulation (e.g., high or low frequency, resulting in or avoiding muscle contraction vs. sensory nerve fiber activation, etc.) prior to use during placement and testing procedures.

Additionally or alternatively, patient feedback may be incorporated into the test procedure, i.e., through the use of software/programming that adjusts the test stimulation parameters based on input/feedback from the patient and/or clinician. This adjustment allows the duration of the test procedure to be minimized while avoiding any potential uncertainty regarding the adjustment of the stimulation parameters. In this non-limiting embodiment, the patient and/or clinician uses a graphical interface mechanism to obtain feedback, such as a controller or tablet GUI as shown in fig. 17, that allows information regarding the results of the test stimulus to be relayed to or in communication with the stimulus generator. Such a controller may include, for example, an input device whereby the patient may communicate sensations (e.g., paresthesias), pain, and/or intensity of contraction to the clinician, as well as the location of such sensations, pain, or contraction on the patient's body. For example, a flat panel GUI displays an image that represents a portion or all of a patient's body, and that allows the patient to select/highlight/draw or other means to indicate an area where stimulation is felt/seen/results in some result. The software determines the appropriate adjustments to the test stimulation parameters and/or suggests to the clinician how to redirect or relocate the system to a new test location and/or where to deploy the lead (e.g., at the current location, at the new test location, etc.). Such a program, system and/or method may be combined with one or more of the other embodiments of the present invention such that such a combination is advantageous for the purposes of the present invention.

An exemplary stimulator may be capable of providing at least the following parameters: amplitude of 0.2-20 mA; pulse duration of 10-200 mus; and a frequency of 5-100 Hz. The stimulator may be connected to wireless clinician programmed software for therapy, software and hardware for a wireless patient controller, and firmware and hardware for a miniature body-mounted stimulator. This configuration allows the clinician and patient to view and adjust the treatment parameters without having to interact directly with the stimulator. This may prevent the patient from having to take off clothing or the like to reach the stimulator during use. In one embodiment, the stimulator may communicate via physical cable, wire, bluetooth, or other wireless technology. The present teachings are not limited to any particular configuration.

The patient controller may also provide a broader graphical user interface including various other options (e.g., data specific to the time of day/type of pain/type of patient activity expected, access to information on pain management, means of communicating with medical professionals, etc.), making it a primary means of initiating and altering therapy. As with the stimulator, the controller communicates with the stimulator (or stimulators if included in the system) and optional programmer unit via physical wires/cables or wirelessly, as described below. The controller may be relatively larger than the stimulator, however, the wireless connection will allow the user to carry the controller in clothing and/or at a convenient distance and location as compared to electrode 934 and stimulator. The connections between the controller, stimulator, and introducer system may include any of those described herein (e.g., standard wired connections, wireless connections-particularly between the controller and stimulator, wired connections that rely on quick release mechanisms, etc.).

The stimulator allows for adjusting the stimulation intensity by controlling the stimulation amplitude and pulse duration, preferably with a single programmable parameter for the intensity. The stimulus intensity itself may be determined by a number of parameters including, but not limited to, stimulus amplitude and pulse duration. For example, the stimulation intensity may be increased by increasing the stimulation amplitude, the pulse duration, or a combination of both. Using a single parameter to control multiple parameters such as stimulation amplitude and pulse duration may reduce the complexity of the process to program the stimulation parameters by reducing the number of parameters that can be changed from 2 or more to 1. As one non-limiting example, the minimum value of the stimulation intensity parameter (e.g., 0) may set the stimulation amplitude and pulse duration to their minimum values (e.g., 0.2mA and 10 microseconds). As another non-limiting example, increasing the stimulation intensity parameter may change the stimulation amplitude, the pulse duration, or both.

In yet another embodiment, increasing the stimulation intensity parameter from the minimum value may first increase the stimulation amplitude while maintaining the pulse duration at the minimum value until a maximum value of the stimulation amplitude (e.g., 20-30 mA) is reached. Continuing to increase the stimulation intensity parameter may then keep the stimulation amplitude fixed at a maximum value while increasing the pulse duration until the maximum value of the pulse duration is reached. In these embodiments, the stimulation intensity is easy to program and can be increased while keeping the pulse duration as low as possible in order to keep the stimulation charge required to activate the nerve fibers as low as possible and enhance the ability of the patient/clinician to selectively stimulate a large diameter in preference to a small diameter fiber. In another non-limiting example, increasing the stimulation intensity parameter from the minimum value may first increase the stimulation amplitude while maintaining the stimulation amplitude at the minimum value. Continuing to increase the stimulation intensity parameter beyond the maximum value of the pulse duration (e.g., 200 microseconds) may then keep the pulse duration fixed at the maximum value while increasing the amplitude until the maximum value of the stimulation amplitude is reached. In this example, the stimulus intensity is increased while keeping the stimulus amplitude as low as possible, which is as low as possible for the power consumption per pulse given charge-holding pulse.

Fig. 18A is a first example given, keeping the pulse duration low. Fig. 18B is a second example, keeping the stimulus amplitude low.

The introducer systems described herein may also reduce the risk of problems after lead placement by reducing the risk of lead breakage. This risk reduction results from the shape of the electrode itself, i.e., in terms of its self-anchoring, migration-resistant, and infection small diameter spiral/coil and its distal anchoring system, and from the reduction in the stress level exerted on the lead during insertion and test stimulation procedures, by being able to retract and protect the electrode during insertion and repositioning.

Other advantages include the ability to allow lead placement and the duration of the stimulus testing process to be minimized. The system also limits the number of percutaneous insertions required, reduces the risk to the patient, allows for efficient positioning and repositioning of the leads for stimulation testing and lead deployment, allows the clinician to correctly and optimally position and deploy the leads with minimal or no additional training, and reduces the time required to make electrical connections for testing. As a result, therapy can be delivered to the patient by the clinician in an environment/scenario that was previously cumbersome, impractical, and/or impossible (e.g., to treat pre-operative, peri-operative, and/or post-operative pain). The introducer also overcomes the limitations of prior systems by minimizing or eliminating the need for: a) Insertion through a plurality of percutaneous devices; b) Repositioning the lead; and/or c) testing for an extended period of time required for the stimulation and/or lead placement process.

One embodiment includes increasing the strength of the coil/helical lead, for example, by incorporating one or more strands of high tensile strength material (such as, but not limited to, MP35N, nickel-chromium-molybdenum superalloys) into the lead. Adding such strands and/or replacing current lead wire strands with such strands or wires increases the fracture resistance of the lead, thereby increasing the utility of self-anchoring, migration resistance, and infection of small diameter coils/helical leads for electrical stimulation systems.

Another non-limiting embodiment includes increasing the strength of the lead by adding new strands/filaments within the open core/center of the helically coiled lead. In this non-limiting example, the new strand/wire will not completely fill the opening. A gap will remain between the outside of the new strand/wire and the inside of the coiled wire. In addition, the new strand/wire will not extend the entire length of the coil-like lead. In this non-limiting example, these two measures help the lead to remain flexible, with axial and radial forces during normal use. When the lead is retracted, the inner diameter of the coil of the lead will decrease as the coiled wire straightens and the coiled wire becomes bonded to the central strand/wire. Thus, the leads have a higher tensile strength and reduced flexibility during the removal procedure compared to the normal use configuration. The new strand/filament in the core may be metal (e.g., 316L or MP 35N), or it may be a polymer (e.g., aramid). Such embodiments may be advantageously combined with other aspects disclosed herein (e.g., adjacent strands/filaments, or even as part thereof, using a stylet).

As noted above, the risk of lead fracture before, during and/or after peripheral nerve stimulation treatment with self-anchored, migration resistant and infection small diameter coil-like/helical leads is minimized because the stresses placed on the leads during lead placement, testing and/or repositioning and deployment procedures are limited. One non-limiting example of an embodiment that results in such a reduction in mechanical stress is a design that includes a contouring (e.g., rounding or smoothing) of the inner edge of the needle/sheath that may contact the lead where it exits the bore/lumen of the needle/sheath.

Preventing breakage and/or damage to any portion of the lead and/or self-anchored electrode tip is critical to ensure maximum therapeutic benefit and reduce the risk of adverse events for the patient. The inventive coiled lead is designed to move with the tissue and skin and to prevent breakage while in the tissue during treatment. However, methods to eliminate other deleterious forces encountered by the wire during wire placement may further reduce the risk of wire breakage, thereby improving the safety of the system and avoiding the need for wire replacement. This can be achieved by the following features: is designed to reduce the path of forces applied and/or transferred from the needle to the lead and/or anchor tip during lead insertion, as well as changes to the method used to make the anchor shape to reduce strain on the lead in the lead.

For example, the boundaries of the needle and/or sheath (e.g., heel, edge, bevel) may be smooth or rounded to prevent sharp contact with a portion of the lead and/or other components of the introducer (e.g., sheath, balloon, which may be negatively affected by the sharp edge of the needle or sheath). In one non-limiting example, manufacturing and/or preparing the introducer needle heel with a rounded edge (e.g., by grinding, blowing sand, or smoothing the surface) would eliminate sharp edges (which weaken the mechanical or electrical connection in the lead) that could press against or come into contact with the lead, thereby reducing the risk of lead breakage. The design and use of rounded edges in introducers prevents breakage or strain from being limited against sharp edges (e.g., the heel of the needle) during insertion of the lead, which may weaken the tensile strength of the lead and cause breakage of the lead. The lead may alternatively be manufactured to reduce the likelihood of lead breakage by reducing the strain placed on the end of the lead during creation of the lead anchor. In the prior art, uninsulated lead anchors are used (e.g., by folding it to create sharp bends), creating points of high strain at the bends in the lead (e.g., anchor, hooks). To prevent such points of maximum strain, the lead anchors may be manufactured by gradually rolling the lead around a ball or pulley system to create a curved (e.g., rounded) anchor (which has no sharp bends) in the lead. In another embodiment, the bent self-anchoring lead ends may be used to secure the lead into tissue after deployment during lead placement. Alternatively, the lead anchor ends may be manufactured in other shapes (e.g., straight, rounded, coiled, serpentine) that allow the lead to be deployed and anchored in tissue, thereby improving the strength and performance of the lead by avoiding sharp bends in the lead ends.

The inner and/or outer needle of the present introducer system uses a fully rounded edge surface that can come into contact with the lead. The fully rounded shape extends throughout the entire cross-sectional shape (e.g., by maintaining a substantially constant radius) in order to eliminate or reduce the risk of wire impingement (which may subsequently increase the risk of wire breakage). The use of rounded or substantially rounded edges, optionally in combination with the elimination of edges or sharp narrow points on the lead in the introducer and throughout the insertion process, increases the reliability and performance of the lead and improves safety profiles and safety margins for the patient.

A prior art repetition of a cutting edge for a needle or other lumen is shown in fig. 19, which includes an exploded small view at the top. These illustrations also reflect European patent No. EP0929330B1, which belongs to Gravelee. Generally, an angled cutting edge E2 is provided at the distal end of the needle/lumen E. In some embodiments, the sharp anterior portion of the cutting edge may be located along the inner diameter of lumen E, rather than on its outer periphery as shown. In contrast to other conventional needles having a top edge E3 that substantially replicates a bottom edge E2, the top at the trailing edge E4 may be partially rounded along its inner diameter edge (i.e., not as sharp as the cutting edge 38). This rounded posterior cutting edge E4 allows tissue to be pierced without a small piece of tissue being cut off by the posterior cutting edge of the needle, which may then be injected into the patient's tissue or into the blood stream, and may lead to downstream embolism (blockage of blood vessels) or abscess. In this configuration, the partially rounded edge E4 of the needle E extends 1% to 60%, and preferably to about 50%, around the circumference of the needle E. Note that a large portion of the cutting edge E4 is still flattened, with the intention that it be necessary to facilitate the cutting action, so that both edges E3 and E4 provide a potential "pinch point" in the case where the needle E is used as an inner sheath. In both illustrations of fig. 19, the anterior cutting edge E2 makes a curvilinear or arcuate incision through the tissue and seals and heals more easily than the resulting curvilinear incision in a blood vessel if a small piece of tissue is removed.

As seen in fig. 20A-20C (including exploded small views at the trailing edge R4), the introducer system has a more fully rounded edge R4 or transition between the inner diameter of the lumen R and the outer surface of a portion of the trailing edge R4 along the curvilinear opening R6. The wire cutting edge R2 is disposed along the opposite side of the opening R6. This property is a significant advantage, particularly at the heel of the chamfer or at the trailing edge, where the lead anchor (not shown) is bent or flexed during development, manufacture, assembly, delivery, use, insertion, positioning and/or repositioning of some or all of the lead in tissue. By rounding this region of the needle (and/or other regions where the electrode is bent or flexed at an acute angle while potentially making contact with the edge surface), the sharpness of the edge is reduced so as to completely eliminate any edge that may cut, sever, scratch, cause unwanted notches, or otherwise damage or impair the function of the lead that may and/or will make contact with the beveled heel. Another desirable attribute of the present invention is that it can incorporate a bevel with a rounded edge such that it allows the introducer and lead to be inserted into tissue without risk of damaging the lead while maintaining a sufficiently sharp (e.g., non-blunt) leading edge and interface to allow it to advance through the tissue.

As seen in fig. 20C, the fully rounded edge may also replicate along any portion of edge R14 associated with slit R16 through which the distal end of an electrode (not shown) may be constrained. In contrast, edge R12 may be entirely rounded, or it may more closely mimic the sharper cutting edge at leading edge R2. The slit R16 may have a similar curvilinear shape as compared to the opening R6, but it is also possible to form the slit R16 as an elongated, oval, slit-like, or polygonal shape, which is positioned offset, parallel or orthogonal to the axis defined by the cylindrical shape associated with the needle R.

The fully rounded aspect of the prior art needle or edge being rounded is different from the rounded edge of the present invention. The prior art describes edge E4 as extending only along the inner circumference of the needle, leaving a narrow point (but one with a slightly less sharp edge). In contrast, the rounded edge R4 extends from the inside to the outside of the needle (i.e., maintains a substantially constant diameter relative to the arc formed by the rounded edge) so that the force applied to the electrode is evenly distributed along the entire surface of the edge R4. In another embodiment, the rounded edge R4 is orthogonal or perpendicular to the circumference of the needle (i.e., the edge extending from the inner diameter to the outer diameter), thereby comprising an elliptical shape, the radius of which may vary. In both cases, the edge R4 establishes a smooth transition without any pinch points, and the term fully rounded encompasses arcs of constant radius as well as ellipses.

As yet another example of the difference between the prior art and the present introducer, the prior art and the present invention are different. The prior art is designed to allow insertion into a blood vessel, while the introducers described herein are intended to avoid contact with the blood vessel and are instead designed to puncture tissue adjacent the nerve. The prior art is also designed to avoid cutting a small piece of tissue, while the fully rounded edge is designed to avoid or reduce damage to the self-anchored electrode prior to and during lead placement, testing, repositioning, and/or deployment procedures.

In contrast to the prior art, the fully rounded edges or surfaces are in contact or potential contact with the leads to eliminate or reduce the risk of lead damage (which may increase the risk of lead breakage). The use of a fully rounded edge effectively eliminates edges or sharp edges, increases lead reliability and performance, and improves safety profiles and safety margins for patients.

Tuohy needles and modified Tuohy needles known in the art have a blunt bevel to allow a catheter to pass through them more safely. Such conduits are of substantially larger diameter to the extent that they must accommodate fluid flow without clogging. In contrast, the introducer system is not designed for catheters, but rather employs a desirably thin gauge needle having an inner diameter (e.g., lumen) that is only large enough to accommodate a thin guidewire in order to allow the system to puncture and advance through tissue. As such, the tutories are not compatible with the design intent of the introducer system, and their excessive diameter would pose a difficulty in accommodating the lead without excessive movement and potential damage to the lead. Further, the distal anchor of the lead rests on the heel of the ramp in a manner that allows the introducer to maintain the pose and position of the lead relative to the introducer as the introducer is maneuvered within human or animal tissue.

The present system for percutaneous placement of small diameter coiled leads also reduces the risk of inadvertent lead shifting. This objective of avoiding lead displacement is achieved with self-anchoring, migration resistant and infection small diameter coil/helical leads. Further, these advantages are particularly advantageous (as compared to prior systems) during an initial period of time in which the lead is left in place within the desired tissue (e.g., before the lead is fully encapsulated within connective tissue or during an indwelling period of time from 1 day to months). Other advantages (possibly in addition to those noted herein) include: the ability to allow lead placement and the duration of the stimulus testing process to be minimized; a reduction in the number of percutaneous insertions required; the risk to the patient is reduced by allowing efficient positioning and repositioning of leads for stimulation testing and proper/optimal lead deployment by the clinician with minimal or no additional training, and by reducing the time required to form electrical connections for testing. Treatment may be delivered to the patient by the clinician in an environment/scenario that was previously cumbersome, impractical, and/or impossible (e.g., to treat pre-operative, peri-operative, and/or post-operative pain).

In certain embodiments, accidental lead displacement is also avoided by relying, at least in some portions of the lead/electrode, on an anchoring mechanism made of a bioabsorbable material (e.g., polyglycolic acid: trimethylene carbonate, polylactic acid, or other suitable bioabsorbable material having sufficient mechanical properties to act as an anchoring mechanism). The use of such bioabsorbable anchors facilitates fixation of the lead in the tissue, thereby avoiding unintended displacement. The use of such anchors may also be designed so that as the lead becomes encapsulated/fixed by tissue growth, the anchor becomes absorbed, thereby reducing the risk of the lead breaking at the end of active treatment upon removal. Over time, the bioabsorbable portion is then naturally contained by the body, leaving only the stimulating portion of the lead securely in place.

A monofilament of material (e.g., similar to a dissolving suture) may supplement the distal anchor along with any number of optional barbs to aid in short term fixation. These filaments and/or barbs can have varying or constant geometries, including a variety of different shapes and thicknesses, which can be made using conventional molding. These ends may be attached mechanically integral with the lead by several suitable methods, examples of which include integration within the open coil of the lead by over-molding the lead or by covering the lead with an existing insulating coating of a secondary extrusion of bioabsorbable material. In addition, the bioabsorbable tip can be attached to the lead by a thermal melting approach (using the absorbable material as an adhesive). This approach allows the present invention to enhance short term fixation and avoid inadvertent dislodgement when using or placing self-anchoring, migration resistant and infectious coiled/helical leads. These bioabsorbable aspects may be used alone or advantageously in combination with one or more aspects of the invention described elsewhere in this disclosure.

Referring to fig. 12A, once the lead is placed in the patient, the introduction device can be separated and removed. The proximal portion of the lead 934 may then be engaged with the lead connector unit 950, as indicated by the arrow. The lead connector 950 may have an Insulation Displacement Connector (IDC) (not shown in fig. 12A and 12B) and a recess 952 configured to receive the lead 934. Groove 952 may include a contact strip with receiving members (e.g., micro-structured barbs, snaps, magnets, etc.) (not shown) to hold lead 934 in place.

Another embodiment of a lead connector is shown in fig. 12B, which eliminates the need for a separate tool, as it may allow for a one-handed pushing mechanism for the clinician and/or patient. Leads (not shown) are received in apertures 952, which may have a tapered, funnel-shaped or cylindrical shape, terminating at connection points of the main housing of unit 950. The lead connector unit 950 may also include a break-away connection, for example, the lead connector end 954 includes a magnet and the opposite end, i.e., the lead connector cable end 956, has an oppositely charged magnet (mated in the embodiment shown in fig. 12B), allowing a clinician, patient, etc. to easily separate the cable 958 from the unit 950. The magnet type or other type of connection may be integrated anywhere along the body of the unit 950. Other removable attachment types are also contemplated for the attachment mechanism, including snaps, adhesives, clips, and the like,(Snap), force fit, or any other suitable connection means.

Additionally or alternatively, the connector 950 may have a rotating element, such as a knob, dial, spool, or post 953. The rotating element may mechanically and/or electrically engage the leads to assist in adjusting the tension of the separable connections, the tension being formed by the electrodes, lead connectors, and leads. The rotating element may include a predetermined tension release or recoil mechanism that responds to the separation force by releasing the excess wire wrapped around the element. In the same manner, the wire connector 950 may achieve this tension release by a slider or other movement that is not necessarily rotational in nature. Just as with the separable aspects of the lead connection, the tension release may occur with a force that is less than or equal to half the force required to displace or move the electrode from its initial position.

The IDC mechanism may assist in connecting the leads 934 into the recesses 952 so as to achieve a connection between the receiving members and the leads 934. In this embodiment, the clinician relies on his or her dominant or non-dominant hand to insert and connect leads. The IDC mechanism may also be capable of stripping any insulation from the leads 934 in order to establish better electrical contact between the leads 934 and the cells 950/grooves 952. The IDC may be integrally formed with the lead connector unit or separately attached thereto.

An exemplary alternative embodiment of an IDC is shown in fig. 21A and 21B. IDC 989 shown in fig. 21A may include a drawer mechanism 990, such as a pivot plate that rotates relative to pivot point PP and in a pivoting direction indicated by arrow PD, that is insertable into and removable from the body of the IDC. The slot 952 (similar in function to that depicted in fig. 12A) bisects a portion of the disk. The slots 952 are of a suitable shape and size to securely engage the leads within the tray and may include slidable portions, jaws, barbs, or the like. The disc 990 is rotated such that the proximal end of the wire is fully within IDC 989, while the other portion extends out of the unit 989. Springs, locks, and guides may also be provided to provide better control of the disc 990 during operation.

In another embodiment shown in fig. 21B, the IDC1089 may have a generally cylindrical shape. IDC1089 may include apertures, slots, or openings 1990 (similar to the functions and features associated with the slots 952 above) into which wires may be inserted. The IDC1089 may include an actuation lever AL to twist or rotate the body of the IDC1089 (i.e., as indicated by the pivot direction arrow PD) relative to the portion containing the slot 1090 such that the wire is secured within the IDC 1089. Barbs (not shown) may be included in the interior of the IDC1089 to remove insulation from the leads to expose the underlying wires, if necessary. Cooperating guides or grooves (not shown) may facilitate relative movement of the bodies 1089, 1090 and may also include stops and locking mechanisms to prevent unintended movement.

The lead connector 950 may be bifurcated to receive a plurality of leads 934. For example, multiple slits or funnels may connect multiple leads to a single stimulator to allow therapeutic stimulation to be provided to different parts of the body.

The connection between lead connector 950 and electrode 934 may be separable. Separability may include, but is not limited to: a magnet, such as an insert molded neodymium magnet, may be formed on one or both ends of the connector and lead (if on both ends, the stimulator will also have a separable connection as described herein). Depending on the manufacturing process, the magnets and how the magnets are assembled together may allow for distinguishing between connection points. For example, the lead connector may have a stepped connection port that mates with a corresponding stepped connection on one of the leads, as shown in fig. 22A. Alternatively, a circular magnet may be seated on top of the connector leads, also shown in fig. 22B. A slight depression or groove or other releasable force fitting may be provided to achieve a "snap-fit" feel experience.

Spring loaded fittings may be used in addition to or in place of magnets. An example of such a fitting is shown in fig. 22C. The fitting is generally described such that it may be employed on any of the components, but particular utility is contemplated at the connection between the lead connector 950 and the electrode 934. Additional shapes, prongs or members may be included. The end a has an inverted Y shape that mates with a correspondingly shaped end B. Additional shapes, prongs or members may be included. The outermost arm C moves, preferably spring-loaded or magnetically, to receive and release the end a (single ended arrow indicates the preferred range of motion). The ends a and B may be assembled in a plane parallel to the double-headed arrow and/or they may be sunk or snapped into place and then released in a direction other than, preferably including perpendicular to, the release direction.

In some embodiments, the lead connector and lead may include separable connections configured such that neither the stimulator nor the lead is displaced when unwanted forces are applied to them or their connections. For example, the connection between the lead and the stimulator may be separable upon application of a predetermined force. The predetermined force may be calculated to substantially prevent movement of the electrode once placed in the proper position within the patient.

Alternatively or additionally, the lead may itself be separable (e.g., in the middle so that it is actually a plurality of leads, e.g., two or more). The leads may be separable at any point between the leads and the stimulator, e.g., the leads may be separable at any end. Still further, the predetermined separable portion may be between the lead and the stimulator along any portion of the length of the lead. For example, two or more leads may be selectively attached at a separation point to separate upon application of a predetermined force. Further, while the present disclosure indicates that the multiple portions are separable, they may also be reattachable. This may allow the system to be used as a fail-safe mechanism to prevent damage and/or injury to the system, components, and/or patient.

In addition to being safely separated only, circuitry in the leads (and/or other components, such as the lead connector) may prevent unwanted stimulation from being delivered during stimulation in the event of separation. By way of non-limiting example, the lead may be a "smart lead" having components plus paths for electrical conduction that minimize the risk of the patient experiencing unwanted stimulation (e.g., minimize or eliminate the possibility of the patient experiencing shock) when the lead is accidentally separated during use.

All of the above connections rely on mating parts. To avoid improper installation, each of the mating pairs may be given a unique shape. Sensors or other circuitry may be employed at the connection points to better enhance the user alert features described herein. Such a sensor or circuit may be intrinsic to the electrical signal delivering the stimulus, or a separate signal may be established.

In one embodiment, as shown in fig. 22D, the connection may include a lead connector lead end plug having at least two-tipped or three-tipped steel electrical contacts that attract to the magnetic armature of the lead connector end.

The leads may optionally be coupled to a stimulator (not shown). The stimulator may include a battery (not shown), a programmable memory unit, and circuitry necessary for therapeutic stimulation inherent to the delivery system. In one embodiment, the battery may be embedded within the lead connector or another electrode. The battery may be thin, flexible and strong. The battery may contain a charge of at least 24 hours of use to maximize use without requiring recharging or replacement. The stimulator may also include a graphical user interface to communicate with the patient and/or clinician. It may contain LEDs or other visual indicia to convey motion, error, or other relevant information regarding the operation of the stimulation system. The stimulator may allow for patient and/or clinician adjustment for operation of the system. In addition, the stimulator may be worn on the patient, minimizing cabling and making the system easier to wear than conventional external stimulators. The stimulator may also be waterproof to be worn throughout the day.

Furthermore, the introduction device may be paired with a custom bandage system that minimizes the risk of lead displacement during use. As shown in fig. 23, the lead 1034 and the lead connector unit 1050 may be protected and attached to the patient by a custom bandage 1060. Bandage 1060 may eliminate the need to secure leads 934 and lead connector 950 with separate tape. The bandage 1060 may be integrated with the lead connector unit 1050 to allow a clinician and/or patient to easily and consistently remove and replace the bandage 1060 without fear of inadvertently pulling out the lead and/or otherwise displacing it. The bandage 1060 may be composed of the same film material as used in standard bandages, such as porous or non-porous films, including but not limited to any polymeric material including but not limited to polyethylene, metallocene-catalyzed polyethylene, polypropylene, polyolefin copolymers, and ethylene vinyl acetate copolymers. The bandage 1060 may also include an adhesive material. Suitable binders may include, but are not limited to, acrylic, dextrin and urethane based binders, as well as natural and synthetic elastomers. The binder may also include amorphous polyolefin, including amorphous polypropylene. In one embodiment, the bandage 1060 may have an adhesive peripheral edge 1062 that includes an optional removable patch 1064. The adhesive peripheral edge 1062 may prevent the leads 1034 from being exposed to any adhesive surface and inadvertently attached to the bandage 1060. The center of the bandage 1060 may include an absorbent pad 1066 configured to cover the entry point of the lead 1034 into the patient. The absorbent pad 1066 may be configured to absorb any fluid exiting the lead insertion site, for example, any type of liquid (including, but not limited to, blood, pus), which may seep from the lead insertion site. The size of the pad 1066 may allow the patient and/or clinician to view the area around the lead exit site to determine the presence of any infection or abnormality. The absorbent pad 1060 may be surrounded by a transparent polyethylene section 1068 of the bandage 1060, which allows the clinician and/or patient to better see the placement of the bandage 1060. Cutouts 1070 in adhesive peripheral edge 1062 of bandage 1060 cover lead connector 1050, eliminating gaps in the bandage seal, but allowing direct contact of the clinician and/or patient with lead connector 1050 during the removal/attachment procedure. During removal, the patient and/or clinician may place his or her fingers over pad 1066 and lead connector unit 950 to substantially prevent lead 934 from pulling against the patient's skin. This may be particularly advantageous for difficult to reach locations on the patient's body as well as on frequently moving body parts such as arms, legs, back, head, etc.

When applying or replacing the bandage 1060 as shown in fig. 24A-24F, the clinician and/or patient may separate the lead connector cable 1056 from the stimulator (not shown) and apply a temporary strip of adhesive 1072 to apply pressure to the lead connector 1056. The clinician and/or patient may apply additional pressure to the lead connector 1056 while removing the bandage 1060 from the patient. The site can then be inspected and cleaned. A new bandage may be applied to the site, the temporary tape 1072 may be removed, and the lead connector 1050 may be reattached to the stimulator.

The present teachings are not limited to any particular treatment or indication. The system may be applied to any type of treatment including, but not limited to, post-operative pain patients or any type of pain patient, particularly chronic pain patients (e.g., neuropathic pain, headache, and/or back pain patients).

The lead connector unit may include a lead storage mechanism to store excess portions of the leads (e.g., when the leads are coupled to the lead connector). The mechanism may reduce the excess length of the lead between the lead connector and the point from which the lead exits the body. This may reduce the risk of being caught on objects and being pulled off and/or destroyed. If the lead is caught, for example, on an external object or from a body part, the excess lead stored on the mechanism may be released rather than displacing or moving the lead from the tissue, thereby breaking the lead (either inside or outside the body), and/or pulling the lead out and separating from the lead connector. In a non-limiting example, the mechanism may be a spool around which the lead is wound, either manually or automatically (e.g., using a spring). In another non-limiting example, the mechanism may be located outside of the lead connector or within the lead connector. In addition, the lead connector may be provided with padding on one or more sides to provide comfort while wearing the lead connector.

The lead connector may also be designed to be easily coupled to a stimulator, and may allow for the use of a one-handed connection, such as by a magnetic connection as noted herein. However, it should be understood that although a magnetic connection is described, the connection may be any mechanical connection in addition to or instead of a magnetic connection. The connection may be oriented at a number of different angles relative to the surface of the skin. In one non-limiting example, the connection is oriented generally perpendicular to the skin. In another non-limiting example, the connection is substantially parallel to the surface of the skin. In yet another embodiment, the connection may be easy for a user to make (e.g., without requiring great flexibility, the connection may even be made without looking at the connector), and strong enough to prevent unintended separation (e.g., due to common body movements or small forces, etc.), but separate when subjected to more intense forces that may displace the lead (e.g., from an external object or body part that pulls or drags the lead connector or a stimulator attached to the lead connector). The connection may prevent the wire from shifting or breaking by separating the wire connector and the wire when the wire is pulled instead of transmitting force along the wire. In one non-limiting example, the magnetic connector may be configured such that the ambient magnetic field is reduced and interference with objects placed in proximity to the magnetic connector (e.g., credit card, cellular phone) is avoided.

Still further, the leads may be directly connected to the stimulator (i.e., the lead connector may be built into or integral with the stimulator). The stimulator may be placed directly over or adjacent the lead exit site to protect the exit site. There may be a transparent window through which the lead exit site may be monitored to facilitate safety (e.g., infection, irritation).

In another non-limiting example, the leads may be connected to the lead connector using receptacles and plugs, and the receptacles may be located on the leads and oriented at an angle (e.g., 90 degrees) relative to the leads. The receptacle may be connected to a plug on the lead connector using a downward force, allowing for a one-handed connection. The very small distance between the magnetic armature of the plug and the permanent magnet structure of the lead connector means that the residual field outside the lead connector is very small, as shown in fig. 26.

The cable may be attached to the stimulator and stored or organized (e.g., wound, coiled) to reduce the length of the lead (or leads) that may become hung up on, for example, an external object or body part. In a non-limiting example, the excess cable may be stored in a storage device attached to the cable, the lead connector, and/or the stimulator. In one non-limiting example, the storage device is a spool around which the cable may be wound manually or automatically (e.g., via a spring). In one embodiment, the cable may be coiled or wound around a reel on the stimulator, and the force on the lead causes the cable to unwind from the reel, rather than separate from the stimulator, transmitting the force to the lead connector and/or the cable.

The stimulation system may include leads that are attached to the stimulator, available in a variety of lengths. In a non-limiting example, the lead having the shortest length that allows for connection between the stimulator and the lead connector may be selected to reduce the risk of the lead hanging on an object or body part and disconnecting the system, displacing the lead, and/or breaking the lead.

In some embodiments, the stimulator may implement coordinated stimulation across two or more stimulators. Alternatively or additionally, the controller and/or programmer unit may enable coordinated stimulation across two or more stimulators. Coordinated stimulation may allow stimulation across multiple stimulators to start and stop in a coordinated fashion to avoid asynchronous activation of muscles on opposite sides of the body (e.g., back or torso), which may lead to imbalance or discomfort. Control of stimulation across multiple stimulators may also prevent simultaneous stimulation, for example to avoid activation of opposing muscles (e.g., biceps and triceps), which may cause discomfort. In one non-limiting example, one of the stimulators, controllers, and/or programmer units may communicate directly with the other stimulators. In another non-limiting example, each stimulator may be connected to a central control unit, which may be another stimulator or may be a non-stimulating control unit. In one non-limiting example, communication between stimulators and/or control units (controllers or programmer units) may be wireless (e.g., via bluetooth, wi-Fi) or wired (e.g., cable).

The battery-powered, body-worn stimulator may generate an electrical current, which may be applied via a lead and/or introducer. In one embodiment, the stimulator is a small box (e.g., with a circular profile and minimal profile height) that is worn on the body via a gel patch electrode that acts as a return electrode and is connected with two snaps that also provide electrical connection. In one embodiment, the stimulator has a minimal user interface (e.g., push button start/stop, LED lights and speaker or buzzer) to provide critical feedback to the patient. For example, if the battery is low or if there is a problem with the stimulus, the light may flash or illuminate (e.g., a different color or a different flashing pattern). This important feedback will alert the patient or clinician to address any issues such as battery failure, gel pad drop out or broken connection. In a non-limiting example with a magnetic lead connector, it is important that the stimulator generates an alarm if the quick release cable is accidentally displaced without the patient's knowledge. Furthermore, lead errors, which cause stimulation to cease due to, for example, high electrode impedance issues (e.g., due to a loss of connection between the skin and the return electrode), and may affect the treatment time of use and the therapeutic benefit received by the patient, and audible or visual alarms of the stimulator prevent this. Further, in one embodiment, the stimulator memory will generate an activity log for recording stimulator usage and errors during treatment. The stimulator log may include a list of errors that occurred, as well as a timestamp of the time of the error that occurred, a history of usage time, including amplitude and stimulation parameter settings used. These features are important to ensure that the patient is able to effectively use the stimulus, and that the clinician can effectively health their use of the stimulus.

An additional embodiment of a breaking mechanism is shown in fig. 25A to 25D. In fig. 25A, a portion of the breaking mechanism is shown as a receiver portion, including the wire/lead contact point CW. The receiver portion may comprise a magnet M of any suitable embodiment including a contact point. The receiver portion may include a ferromagnetic stator 1110, which may act as a pathway holder. Fig. 25B shows the mating portion of the breaking mechanism, which is plug 1112. The plug may include a ferromagnetic retainer path 1113 and contacts 1114. The leads may be operatively attached to the plug 1112.

As shown in fig. 25C, the breaking mechanism may include a spring-loaded plunger mechanism PM. The plunger mechanism employs a pair of biasing members BM that can urge the plungers toward each other when the plugs are inserted into the receptacles. This can fix the breaking mechanism together. The force employed to hold the breaking mechanism together is defined such that any degree of force applied to the system that exceeds such force will cause the plug to separate from the receptacle, for example, if there is a force applied to the lead due to the lead hanging on something. This will generally protect the system. In particular, it generally prevents the leads and/or electrodes from becoming separated or moving from their intended positions.

Although embodiments of the present disclosure have been illustrated in the accompanying drawings and described in the foregoing detailed description, it will be understood that the disclosure is not limited to just the embodiments described, but is capable of numerous rearrangements, modifications and substitutions without departing from the scope of the following claims. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present specification, but one of ordinary skill in the art may recognize that many further combinations and permutations of the present specification are possible. Each of the components described above may be combined or added together in any permutation to define an introduction device and/or an introduction system. Accordingly, the specification is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim. It is intended that the appended claims cover all such modifications and variations as fall within the scope of the claims or their equivalents.

Embodiments of a system for testing, locating, introducing, and deploying leads for percutaneous peripheral nerve stimulation include a percutaneous cannula, a stimulation probe, and leads and an introducer. The percutaneous sheath may also be referred to as an introducer sheath or an introducer sheath without changing the components involved. The stimulation probe may also be referred to as a test needle or test needle without changing the components involved. The introducer may also be referred to as an introducer needle or introducer needle without changing the components involved. The percutaneous cannula or introducer sheath may advantageously consist of a hub and a shaft with an inner lumen, the distal portion of the sheath forming the terminal opening. The stimulation probe or test needle may advantageously consist of a hub and a shaft, the distal end of which may comprise one or more bevels, and the shaft has an outer diameter that is small enough that it may enter the lumen of the percutaneous cannula with minimal friction, but there is insufficient space between the two components to allow tissue to be clamped between them during insertion into the skin, muscle or other tissue. The introducer may advantageously be comprised of a hub and a shaft having an inner lumen of sufficient diameter to allow the stimulation lead to reside therein and pass therethrough, the distal portion of the needle being comprised of one or more beveled surfaces forming a terminal opening, the outer diameter of the introducer needle shaft being sufficiently smaller than the outer diameter of the percutaneous sheath lumen such that the introducer having the stimulation lead therein and anchors secured to the edges of the introducer lumen may be inserted through the percutaneous sheath lumen without damaging or destroying the stimulation lead.

Another embodiment of a system for testing, locating, introducing and deploying leads for percutaneous peripheral nerve stimulation includes, in part, a percutaneous cannula, a stimulation probe, and leads and an introducer. The percutaneous cannula or introducer sheath may advantageously consist of a hub and a shaft with an inner lumen, the distal portion of the sheath forming the terminal opening. The stimulation probe or test needle may advantageously consist of a hub and a shaft, the distal end of which may comprise one or more bevels, and the shaft has an outer diameter such that it may be inserted into or through the lumen of a percutaneous cannula while avoiding friction that prevents the components from moving without damaging the position of the cannula while also avoiding seizing tissue between the two components during insertion into skin, muscle or other tissue. The introducer may advantageously be comprised of a hub and shaft having an inner lumen of sufficient diameter to enable the stimulation lead to be carried therein and advanced therethrough, the distal portion of the needle being comprised of one or more beveled surfaces forming a terminal opening, the outer diameter of the introducer needle shaft being sufficiently smaller than the outer diameter of the percutaneous cannula lumen such that the introducer with the stimulation lead therein and anchors secured to the edges of the inner lumen of the introducer may be inserted through the percutaneous cannula lumen while avoiding damage or destruction to the stimulation lead.

As one non-limiting example, the introducer sheath may be inserted with a test needle, which may be implemented as a solid metal needle without a lumen, left inside. The stimulation test can then be performed through the test needle and the system can be repositioned freely as desired without deploying leads. After the desired position is found, the test needle will be withdrawn while the introducer sheath remains in place. The introducer needle (with the guidewire) can then be inserted through the lumen of the introducer sheath. The introducer sheath and introducer needle may then be withdrawn together to deploy the lead.

In one non-limiting example, the percutaneous cannula may include a hypodermic needle having an outer diameter of about 1.49-1.51mm, 1-2mm, and/or 0.5-2.5mm and an inner diameter of 1.36-1.4mm, 1.01-1.99mm, and/or 0.51-2.49 mm. The length of the needle portion of the cannula may be 90-100mm, 60-130mm and/or 30-160mm. In one embodiment, the length of the needle will be sufficient to allow targeting of the deeper nerves (e.g., sciatic nerves) of a heavier patient. In another embodiment, the length of the needle may be minimized such that the torque from the weight of the hub is reduced when directed against a shallower nerve (e.g., the femoral nerve), thereby reducing the tendency of the component to interfere with the final position of the needle tip and lead.

In one non-limiting example, the stimulation probe may have an outer diameter such that it acts as a non-coring insert while within the percutaneous cannula (e.g., in one non-limiting example, if the introduction cannula has an outer diameter of 1.49-1.51mm, the outer diameter is 1.3-1.4 mm). The length of the needle portion of the stimulation probe may be about 120-125mm, 70-150mm, and/or 35-180mm. In one embodiment, the length of the stimulation probe is longer than the percutaneous cannula so that the test stimulus can be delivered through the electrode portion of the stimulation probe.

In one non-limiting example, the introducer needle can have an outer diameter such that when the lead anchor is secured to the edge of the distal lumen edge, the introducer needle and the lead anchor can pass through the percutaneous sheath lumen without damaging the lead anchor. The outer diameter of the introducer needle may desirably be 0.902-0.914mm, 0.7-1.1mm, and/or 0.35-2.35mm. In one embodiment, the inner diameter of the introducer needle may desirably be 0.749-0.800mm, 0.5-1mm, and/or 0.3-2.3mm. The inner diameter of the percutaneous cannula must be large enough to allow the body of the lead to reside therein and be withdrawn therethrough. The length of the needle may be about 120-130mm, 70-150mm and/or 35-180mm. In one embodiment, the length of the introducer needle is longer than the percutaneous cannula such that the entire anchor of the lead protrudes beyond the distal end of the percutaneous cannula into the tissue such that the lead is deployed.

The anchor of the lead bent over the first edge of the terminal opening of the introducer needle can cause the lead to engage tissue, thereby causing the lead to self-anchor as the introducer needle is withdrawn.

The test needle need not have an inner lumen (i.e., it may be a solid needle), which may advantageously avoid tissue coring, tearing, and/or other types of tissue damage. The test needle may be made of any material that is electrically conductive, capable of retaining a sharp tip, and that can be safely inserted into the human body or biocompatible. The test needle may also be made of a non-conductive material if certain parts of the test needle or parts thereof are capable of conducting electricity. One of ordinary skill in the art will recognize that many materials, including various metals, meet these requirements. In one embodiment, the test needle may be made of stainless steel.

The introducer needle and/or the test needle can have one or more bevel surfaces. Having one or more bevel surfaces is desirable because it allows the needle to be inserted into tissue without the use of any surgical (or other) tools (e.g., scalpels).

The system may have a first edge of the terminal opening of the introducer needle that is rounded such that forces applied to the stimulation lead during guiding, positioning, and deployment are distributed over the surface of the terminal opening edge. A rounded edge is desirable because it can avoid damaging or twisting the lead at the bend of the anchor when the lead is pressed against the edge during insertion through tissue (e.g., muscle, fascia plane, skin, etc.). This in turn may prevent or reduce the incidence of lead breakage during lead insertion, lead retention, or lead removal. In one embodiment, the rounded portion of the first edge may consist of 5-30% of the entire edge formed by the terminal opening, while the remainder of the edge remains a sharp transition edge formed by the chamfer. In another embodiment, the rounded portion of the first edge may consist of 30-50% of the entire edge, centered on the heel of the terminal opening. In yet another embodiment, the rounded portion of the first edge may consist of 50-95% of the entire edge.

In one non-limiting example, the rounded portion of the edge is steeper on the inner portion of the lumen than on the outer portion of the needle such that the anchor is directed away from the outer surface of the introducer needle. Having a higher rounded edge on the inner portion of the needle may desirably allow the lead anchor to be further anchored into tissue during lead deployment.

In another non-limiting example, the rounded portion of the edge is steeper on the outer portion of the needle than on the inner portion of the lumen such that the anchor is directed toward the outer surface of the introducer needle. Having a higher rounded edge on the outer portion of the needle may be desirable to minimize damage to the tissue during insertion of the lead into the tissue or insertion or through the lumen of the introduction sheath.

In yet another non-limiting example, the rounded portion of the edge may be evenly distributed between the inner portion of the lumen and the outer portion of the needle so that the force applied to the anchor is distributed as widely as possible. Having rounded edges evenly distributed between the inner and outer portions of the needle may desirably minimize damage to the lead during insertion of the lead into tissue and/or insertion or through the lumen of the introduction sheath.

It may be advantageous for one or more parts of the system to have an enhanced echogenic surface. One skilled in the art will recognize that this may be accomplished in a number of different ways. The enhanced echogenic surface may desirably enhance needle visibility under ultrasound guidance, potentially reducing risk to the patient by helping to avoid puncture or damage to critical structures such as nerves, arteries, and veins. In addition to the test needle and the introducer needle, it may be advantageous for the introducer sheath to have an echogenic treatment so that the sheath can be adequately visualized when those other components are not in place within the introducer sheath and so that the complete path of the needle under the skin can be clearly observed under ultrasound. Echogenic markers may desirably be incorporated into only portions of the component surface such that they are capable of visualizing distance measurements and/or are capable of determining the relative position of the test needle and the introducer sheath or the introducer needle and the introducer sheath. In a non-limiting example, the echogenic marker may be placed on the introducer sheath at a distance from the echogenic marker on the test needle, the echogenic marker being visible under ultrasound when the components are fully locked or engaged together. Desirably, the echogenic markings on the introducer needle can be the same set distance from the markings on the introducer sheath when the two components are fully locked or engaged together.

In one embodiment, the conductive test pins may have integrally connected electrical connectors, that is, may have plugs that may be integrally connected via one or more lengths of cable. The electrical connector may desirably mechanically and electrically mate with the pin. The built-in plug in the hub of the test needle avoids the need to use external connector components to facilitate stimulus delivery during testing.

The conductive test needle or stimulation probe may be coated with an insulating material except for the exposed conductive portion of the needle that is adjacent to and either engages or does not engage the distal-most end of the needle. The exposed portion allows for delivery of test stimulus through the test needle. In one non-limiting example, the conductive exposed portion of the needle or electrode may have a surface area of 1-10mm ². In another non-limiting example, the electrode may have a surface area of 10-100mm ². In yet another non-limiting example, the electrode may have a surface area of 100-500mm ².

The introducer needle may have an electrical connector that integrally mates with the conductive introducer needle such that the electrical connector mechanically and electrically mates to the needle. The built-in plug in the hub of the introducer needle avoids the need for stimulation through the lead using an external connector component. The conductive introducer needle may be coated with an insulating material in addition to the exposed conductive portion of the needle (including or desirably excluding the terminal opening). In one non-limiting example, the conductive exposed portion of the needle or electrode may have a surface area of 1-10mm ². In another non-limiting example, the electrode may have a surface area of 10-100mm ². In yet another non-limiting example, the electrode may have a surface area of 100-500mm ². The exposed portion enables the test stimulus to be delivered through the tip of the needle. Because the tip of the needle also contacts the lead electrode and/or anchor, stimulation is delivered through the lead.

In embodiments of the system, the percutaneous cannula or introducer sheath may be coated with an insulating material along part or all of its length, including an outer portion of the sheath and/or an inner portion of the sheath lumen. This may help ensure that stimulation is not delivered through the introducer sheath, but only through the test needle or the introducer needle or the lead, helping to ensure proper positioning prior to deployment of the lead.

In some non-limiting examples, the insulating coating used on the percutaneous sheath, stimulation probe, and/or introducer needle may include a material such as parylene, and in one example, the coating thickness is 0.0025-0.0051mm and/or 0.0001-1mm.

The introducer sheath, test needle and/or introducer needle may incorporate an ergonomic, lightweight hub into the proximal end, the hub having a textured surface to provide grip and control during insertion into tissue or adjustment within tissue. The hub can be attached to the needle in a variety of ways including solder crimping, gluing, and/or overmolding. The proximal surface of the needle may be roughened to facilitate engagement of the hub with the needle. An ergonomic hub is important because it provides better control of the needle during insertion, especially in patients with stiffer skin, where insertion of the system is challenging without sufficient position to grasp the introducer system. Minimizing the weight of the hub is important because this portion of the system provides maximum torque to the system when it is left in place during testing, tends to deform/displace tissue, and may create a discrepancy between stimulation during testing and stimulation after lead deployment.

A non-limiting example of a lightweight hub may be desirably one whose weight avoids creating torque on the system that displaces the needle tip beyond 0.25mm, 1mm and/or 5mm when one third or more of the length of the needle is left in the tissue. Another non-limiting example of a lightweight hub may desirably consist of a hub that weighs no more than one-fourth, one-third, one-half, three-quarters, and/or nine-tenth of the total weight of the component.

The hub of the test needle and the hub of the introduction sheath may be reversibly locked or connected together by means such as a snap, twist lock or other means of making a temporary connection. Locking the test needle and introducer sheath together ensures that the components stay in place relative to each other during insertion, testing, and repositioning. The locking mechanism may be reversible such that once the correct position is identified, the test needle may be withdrawn through the introducer sheath without changing the position of the introducer sheath. In one non-limiting example, one or more protrusions or projections on the hub of the stimulation probe may fit into slots or keyways in the hub of the percutaneous cannula, allowing the hubs to mate together with little twisting of the two components relative to each other. The mechanism may reduce the force applied along the length of the needle required to unlock the two components from each other, which in turn avoids displacement of the percutaneous cannula from the target site.

The hub of the introducer needle and the hub of the introducer sheath may be reversibly or irreversibly locked or connected together by, for example, a snap, twist lock, or other means of forming a temporary or permanent connection. Locking the introducer needle and introducer sheath together ensures that the components stay in place relative to one another during lead insertion and deployment. Such a locking mechanism may not be easily reversible because once the introducer needle is fully inserted into the introducer needle sheath, the two may be withdrawn together during guidewire deployment.

In one embodiment, the inner surface of the introducer sheath may be coated with a lubricious coating such that friction between the introducer sheath and the components (e.g., test needle, introducer needle, and guidewire) inserted or withdrawn therethrough is reduced. Applying a lubricious coating to the inner surface of the introducer sheath may prevent movement of the sheath during insertion or withdrawal of the various components and may reduce or prevent wear or damage to the lead anchor during insertion of the introducer needle and the lead. One non-limiting example of such a lubricant is a silicon lubricant.

Fig. 26 shows a perspective view of a detachable three-part introducer system 1000. As described above, the introducer sheath or percutaneous cannula 1010 includes an integral hub and handle. The stimulation probe or nested needle 1020 also has an integral hub and handle, as well as the necessary electrical connectors 1022 to attach to the pulser or other stimulator via connector 1002. The introducer or introducer needle 1030 includes an integral hub and handle plus an electrical connector 1032 for attachment to the connector 1002.

Needle 1030 is configured to carry and deploy a stimulation lead as described herein. In one embodiment, the needle may comprise 20 gauge (i.e., 0.902 to 0.914mm outer diameter) stainless steel, such as full durometer 304 stainless steel. The lumen defined by needle 1030 has an inner diameter of about 0.749 to 0.800mm. The length of the introducer needle 1030 is relatively longer than the percutaneous cannula 1010 and desirably about the same as the length of the stimulation probe 1020 (e.g., 12 to 13 cm). The additional length of the integral hub and handle of the needle 130 and probe 1020 may be between 1-2cm with an optimized, ergonomic shape and sufficient clearance for easy attachment, insertion and removal of the stimulation lead along the axial length of the stimulation lead (not shown).

Conversely, stimulation probe 1020 may be a solid needle in order to avoid coring upon insertion. Sufficient tolerance should be provided between the outer diameter of the probe 1020 and the inner diameter of the cannula 1010 to allow these components to move without excessive space to allow tissue to be captured therebetween. The probe must be conductive or, alternatively, configured to carry an integral test electrode that is properly connected to a pulse generator (not shown). Stainless steel is the material of choice due to its durability and strength.

Percutaneous cannula 1010 is preferably a 17 gauge (1.49 to 1.51mm outer diameter) needle having a lumen with an inner diameter of 1.36 to 1.40. The inner lumen may optionally receive either the probe 1020 or the introducer needle 1030, although the cannula 1010 should be shorter (e.g., 5-10cm, plus an optional handle/hub of additional length 1-3 cm). The handle must be able to accommodate the insertion, removal, and necessary movement associated with the probe 1020 and needle 1030.

The hub and handle assembly may be welded or crimped to the associated needle/cannula with an additional overmold. The outer surface of each component 1010, 1020, 1030 may be roughened to allow for proper coupling of the hub with the needle/cannula. In the same manner, other portions of these components may be smoothed, lubricated and/or coated for ease of use and for possible echo/visualization purposes as described above.

All materials of the system 1000 should be biocompatible and lightweight, with plastic being the preferred complement of steel components. Furthermore, the hub/handle should be balanced sufficiently well and the weight allows for a one-handed operation of the system 100. To this end, some embodiments may advantageously ensure that the probe 1020 and the needle 1030 are as similar as possible in terms of length, weight, and feel. Grip rings, flanged wings and/or contours within the handle itself may also be provided to enhance overall use.

The locking mechanism 1040 allows for reversible or irreversible connection between the connectors 1022, 1032 and the hubs/handles of the respective components 1020, 1030. In each case, the connector 1002 is coupled to a proximal lead that extends out of the members 1020, 1030.

In the case of inserting or removing components relative to one another, a non-limiting example of an acceptable frictional force is a force such that the force required to advance, insert, withdraw, remove and/or otherwise reposition the components relative to one another is less than the force required to advance, withdraw, remove and/or otherwise reposition the introducer sheath relative to the tissue it is indwelling with. In a non-limiting example, an acceptable frictional force may be one in which the force causes the percutaneous sheath to produce a displacement in tissue of less than 1mm, 3mm, and/or 5-10 mm.

The use of vibrations to provide anesthesia and/or to reduce pain during insertion of the needle into the tissue may utilize an external vibrator applied to the skin or tissue. The systems described herein may also utilize vibrational anesthesia by incorporating a vibrating part or component into one or more components of the system such that an external vibrator may not be required and/or may be used external to one or more components of the system, which may vibrate to relieve pain (or produce anesthesia) without an external vibration source, i.e., the vibration source may be integrated into the system. Non-limiting examples of components that may vibrate individually or collectively to alleviate pain from needle insertion include percutaneous cannulas, stimulation probes, introducers, outer sheaths, inner sheaths, and/or body-worn stimulators, including but not limited to any combination of the foregoing components. Vibration may be started and/or stopped automatically or manually. In one non-limiting example, vibration may be initiated automatically as the needle moves such that pain is optimally relieved during needle insertion and/or repositioning. One or more vibrating components (such as motors) may be incorporated into the hub of one or more needle components and/or may be incorporated into a body-worn stimulator. There are situations in which vibration may be desirable and in which vibration may be undesirable, and the present system may be configured and/or programmed to incorporate, use, activate and/or turn on vibration as needed and only when needed, such that vibration is not incorporated, used, activated and/or turned off when vibration is not needed and/or when vibration may be partially and/or wholly confused and/or limited in utility by other aspects of the system. As a non-limiting example, some stimulation parameter sets may be desirably used to produce muscle activation and pain relief, and while the production of muscle activation is generally comfortable, there are situations where muscle activation may produce temporary discomfort when a needle is present (e.g., while the lead is not present after the lead is deployed and the remainder of the lead introduction system is removed). When a needle introducer is present, discomfort that may be caused by muscle activation may be alleviated by mechanical vibration. The present teachings can selectively activate vibrations when some, but possibly not all, of these parameter sets or stimulus settings are selected, used, and/or delivered. In these situations, the use of vibrations may have significant benefits to the comfort of the procedure, to expedite or accelerate the procedure, and/or to improve the efficiency, safety, and/or success rate of the procedure. As another non-limiting example, it may be desirable to use some set of stimulation parameters to avoid muscle activation, and instead produce pain relief without muscle activation. The sensation created by the stimulus may provide guidance regarding the correct, optimal, and/or preferred lead position, electrode position, needle position, introducer position, stimulus setting, and/or procedure. Furthermore, the generation of vibration sensations caused by electrical stimulation and/or in some way vibration-like sensations (e.g., vibration-like sensations) without mechanical vibration can be used to guide the proper, optimal and/or preferred lead position, electrode position, needle position, introducer position, stimulation settings and/or procedures. In this case, the present teachings can be selectively disabled, turned off, deactivated, not turned on, and/or not using mechanical vibration to achieve optimal, correct, and/or preferred delivery and/or positioning of the device, electrical stimulation, and/or therapy.

The use of mechanical stimulation in combination with electrical stimulation presents unique challenges that can be overcome with the present teachings. As a non-limiting example, a challenge is that simply adding mechanical vibrations during use (e.g., insertion, movement, repositioning, testing, delivery, deployment, and/or extraction) of an electrical stimulation (e.g., lead) introducer system (e.g., peripheral nerve stimulation system) may obscure, confuse, and/or otherwise detract from the ability to distinguish a response generated by mechanical stimulation (e.g., vibration) from a response generated by electrical stimulation. For example, both types of stimulation may produce a vibration-like sensation. The present teachings can overcome this challenge, and the challenge can be overcome by a system that determines when and how to selectively deliver each type of stimulus (mechanical and/or electrical) as needed to minimize discomfort and/or pain in the procedure in which the introducer system is used (e.g., inserting, testing, repositioning and/or identifying or finding the optimal location as needed, deploying the lead, and withdrawing the introducer, leaving the lead in place for effective electrical stimulation). The frequency and/or intensity of the mechanical stimulus may be varied, adjusted and/or regulated, and/or the frequency and/or intensity of the electrical stimulus may be varied, adjusted and/or regulated to produce different or completely different responses, sensations, pain relief and/or sensations, whereby these responses may be distinguished. As a non-limiting example, mechanical (e.g., vibration) stimulation may be used to alleviate discomfort during delivery of an electrical stimulation system intended to activate muscles to relieve pain. In this case, the activation of the muscles around the needle may lead to temporary discomfort, which may be relieved by vibrations (mechanical stimulation) of the introducer system. Additionally, the correct activation of the muscle may be used as a control signal to indicate that the correct lead and/or electrode position has been identified and/or to indicate that the correct stimulation parameters have been identified. it is also possible to determine that the correct lead and/or electrode position has been identified and/or to determine that the correct stimulation parameters have been identified without patient feedback, without conscious patient feedback (e.g., the patient may be sedated and/or under anesthesia), without patient sensory reporting. The same system may also be delivered for pain relief without activating muscles, in which case feedback and/or sensory reporting by the patient may be necessary, beneficial and/or helpful in that the correct lead and/or electrode position has been identified and/or the correct stimulation parameters have been identified and/or the repositioning or repositioning of the introducer, lead and/or electrode and/or test is continued until the correct position and/or parameters have been identified. In situations where the goal is to alleviate pain without activating muscles, the present system is able to determine the correct device location and/or parameters without causing vibrations to interfere with the patient experience and/or reported response and/or sensation. The present system may achieve this goal by varying, adjusting and/or adjusting the frequency, intensity and/or position of mechanical stimuli (e.g., vibrations) relative to the sensations produced by the electrical stimulation and/or relative to the frequency and/or intensity of the electrical stimulation itself. As non-limiting examples, in some cases, mechanical stimulation (vibration), electrical stimulation, and/or both may be deactivated and/or turned off, and the duration and timing of the deactivation (off) period may be related to each other (e.g., one turned off and the other turned on, or they may be turned on and/or turned off simultaneously, and/or any or specific phase lag (delay) and/or phase lead may be added or subtracted, which may account for the continuation of previous signals and/or sensations, as one and/or both of the mechanical and electrical stimulation may produce a sensation longer than the duration of the signal or stimulation) and/or there may be specific timing considerations with respect to the current function of the device (e.g., the mechanical stimulus may only be applied in whole or in part while the introducer is being moved and/or being moved). thus, the present teachings can achieve the goal of reducing or eliminating discomfort of inserting, moving, using, and/or removing an introducer system while still enabling the introducer system to achieve its overall goal of being able to determine the correct device location and/or electrical stimulation parameters without changing, adjusting, timing, and/or adjusting mechanical stimulation (e.g., vibration) and/or electrical stimulation to produce different or completely different responses, sensations, pain relief, and/or sensations, such that the responses from the mechanical and electrical stimulation can be differentiated as desired.

The present invention also enables vibrations to be generated in a manner, manner and location such that tissue is not damaged by the introducer system and lead and/or electrode positions are not undesirably altered.

The use, instructions, and/or provided instructions of the devices, systems, and methods for treating pain described herein may be closely coupled with the actual use of any or all of the inventive components. In one non-limiting example, a clinician may be trained to hold the percutaneous cannula in place with one hand while the other hand is used to unlock and remove the stimulation probe and replace it with a lead and introducer. In another non-limiting example, a clinician may be trained to place, test, deploy, and/or use the system with one hand.

Embodiments of the present teachings may utilize a percutaneous cannula (or an open cannula, slotted cannula, and/or cannula, and/or needle having a channel or opening along the length of the needle) that is open-sided, as well as a stimulation probe and lead and introducer. An open sleeve may be required where the open portion of the needle is wide enough to allow the anchor of the lead to pass through the lead without damaging the lead as it is suspended over the terminal opening of the introducer, with a portion of the wall of the needle extending along its entire length removed and/or not included during manufacture. Desirably, the percutaneous cannula may have a diameter large enough to enable the introducer needle to pass through it while limiting the overall diameter of the cannula diameter. In one non-limiting example, the stimulation probe may optimally fit the percutaneous cannula such that the system avoids capturing, tearing, hooking, and/or otherwise undesirably damaging tissue between the two needles during insertion or repositioning of the system in tissue. In one embodiment, the open-sided percutaneous cannula and introducer needle can include one or more features that enable proper alignment or operative alignment of the features during insertion of the introducer into the cannula. These alignment components can be implemented in a variety of ways including, but not limited to, one or more direction indicators, one or more physical protrusions or slides incorporated into one or both of the hub and/or needle, and/or one or more direction locking or guiding mechanisms. Aspects of the components described elsewhere in this disclosure may also be advantageously applied to these components, or aspects described herein may be applied to components described elsewhere in this disclosure.

In one embodiment, the split sleeve, along with the stimulation probe and lead and introducer, may incorporate multiple test electrodes along the length of the stimulation probe. Test stimulus may be delivered through any of these electrodes as desired. While maintaining the position of the outer sleeve, the probe may be removed and replaced with a lead and its introducer. The lead and introducer may desirably be positioned to align the anchor of the lead with the position of any location previously occupied by one of the test electrodes, whereby the lead may be deployed. Positioning of the lead and introducer relative to the test electrode location may be accomplished in a variety of acceptable ways, including but not limited to using markers, physical stops or notches, or by mechanical mechanisms that automatically deploy the lead at the desired location.

Fig. 27A-27D and fig. 28A and 28B illustrate various views of a three-part introducer system as described above. These views, as well as the view of fig. 26, may also be combined with the split sleeve method described below.

Fig. 29A shows a perspective view of a percutaneous cannula. The features are similar to those identified above in fig. 26 and 27A. However, as seen in the exploded cross-sectional view, the opening extends along a longitudinal axis of at least one side of the sleeve. This lack of material reduces the overall outer diameter of the introducer system, allowing smaller size components (e.g., 19-gauge cannulas and 21-gauge introducer needles) to be used throughout the system. The resulting slit may also be used as a guide for a probe and/or an introducer needle. In some embodiments, a plurality of openings may be provided and/or the openings may be provided in a spiral or semi-spiral manner.

Fig. 29B is a perspective view of a stimulation probe, also as described above in fig. 26 and 27B. One potential difference is that the probe (shown as a solid non-coring needle) may have one or more flanges extending along all or part of its longitudinal outer surface. The flange may cooperate with an opening in the sleeve to serve as a guide and/or for other purposes.

Fig. 29C is a perspective view of an introducer needle, as also described above in fig. 26 and 27C. Here, the needle may be provided with a pair of guide flanges (although a single flange as shown in fig. 29B is also possible). Further, the needle may include a plurality of flanges or protrusions, such as two, three, four, five, six, etc. Still further, the needle may include a single flange or protrusion. The flange or projection may extend a portion of the length of the needle (e.g., one-fourth, one-half, three-fourth, etc.) or the entire length of the needle. In another embodiment, a distal anchor, which may be positioned outside of the introducer needle itself, may be aligned in or near the opening of the cannula.

Fig. 30 depicts an exemplary embodiment of three different needles (outer cannula, outer cannula with probe, outer cannula with introducer). The first needle comprises an outer cannula, which in some embodiments may comprise a needle having an incomplete circumference, and which forms a slit or side-opening needle with a hollow core, hole or lumen. The second needle comprises a stimulation test probe, shown inserted into the outer cannula, which may comprise a solid needle (not hollow, without holes). The third needle includes an introducer having a hollow bore to receive and deliver the lead and a lead anchor for deployment.

Fig. 31 depicts a close-up of an exemplary embodiment of the end of each of the three needles in the embodiment of the introducer system shown in fig. 30. Starting with the outer cannula on the left, then the cannula of the insertion probe, then the cannula of the partial insertion introducer and the lead, then the cannula of the complete insertion introducer and the lead. Note how the lead anchor passes through a slot in the outer sleeve, which is shown fully inserted through the slot in the outer sleeve.

Turning to fig. 32-48, an embodiment of an intake system 1200 is shown. In general, the introduction system 1200 can include a needle 1210, a housing 1230, an actuation mechanism 1250, a lead 1290, and one or more cannulae 1300. In one embodiment, lead 1290 can be fully contained within introducer system 1200 until the deployment mechanism is actuated to transfer lead 1290 to the exposed position and facilitate placement of lead 1290 within the desired tissue.

In one embodiment, the introduction system 1200 may include a plurality of cannulas 1300. It should be noted that although the term cannula may be used to describe these embodiments, terms such as sheath, lumen, cannula, tube, needle, etc. may also be used and these terms may be used interchangeably unless otherwise indicated by the present disclosure or context. In one embodiment, the introduction system 1200 may include a plurality of nested cannulas 1300 or telescoping cannulas 1300. For example, the diameter or circumference of the sleeve 1300 may be sequentially reduced such that the outer diameter of the inner sleeve is less than or approximately equal to the inner diameter of the corresponding outer sleeve, and vice versa, wherein the inner diameter of the outer sleeve is greater than or approximately equal to the outer diameter of the corresponding inner sleeve. It should be noted that the sleeve 1300 may be considered as an outer sleeve (e.g., engaged with an inner sleeve having a smaller diameter that is capable of nesting therein) as well as an inner sleeve (e.g., engaged with an outer sleeve having a larger diameter that is nested therein), acting as an intermediate or middle sleeve between a smaller sleeve and a larger sleeve, for example. Multiple nested cannulas 1300 or telescoping cannulas 1300 can facilitate precise insertion and deployment of needle 1210 of introduction system 1200 and placement of lead 1290 to more effectively deliver electrical stimulation and achieve a desired therapeutic effect.

Fig. 32 shows an example of a needle or assembled needle/cannula set 1210 that may be used with the introduction system 1200 and potential depth/indicator markings that may be used. For example, needle 1210 may be used as second cannula 1330 as described herein. For example, needle 1210 may be used as first sleeve 1310 as described herein. For example, needle 1210 may be used individually as a set of assembled needles or cannulas, such as first cannula 1310, second cannula 1330, and/or third cannula 1350, as a combination of any two or all three cannulas. For example, during insertion and deployment of the introduction system 1200, the needle 1210 may be used as an assembled set of trocars, e.g., a first cannula 1310 and a second cannula 1330, e.g., an outer/most visible cannula. Needle 1210 may have a distal end 1213 and a proximal end 1216. The proximal end 1216 may be inserted into the patient's tissue to facilitate placement of the lead 1290 in the same area. Needle 1210 may include representative indicia 1219 to aid in conveying to a user the stage of insertion and deployment of needle 1210 within introduction system 1200. For example, representative markings 1219 on the needle may be used to communicate the depth of placement of lead 1290 and the "pass/fail" criteria. The "pass/fail" criteria may desirably ensure that a sufficient length of lead 1290 is deployed under the skin to mitigate lead migration, ensure proper lead deployment, and/or ensure that the lead exit site is a sufficient distance from the lead distal tip.

As shown in fig. 32, needle 1210 may include a plurality of representative marks 1219. The representative indicia 1219 may communicate a desired depth of the needle 1210, a continuous depth of the needle 1210, proximity of insertion of the needle 1210 to the desired depth, and the like. It should be noted that the representative indicia 1219 may vary and may be customizable to represent or convey any information as desired. Different markers 1219 may also represent similar information (e.g., desired depth) depending on the desired lead 1290 placement, location of electrical stimulation, etc. The introduction system 1200 may include a window (e.g., window 1231) in a housing (e.g., housing 1230 described herein) that allows a user to view the representative indicia 1219, or the representative indicia 1219 may be used to communicate the depth of the needle 1210 once exposed from the housing, nested cannula, etc. For example, the housing 1230 of fig. 36 includes a cross-sectional window or port 1231 that can display the current state of the introduction system 1200 (e.g., deployed, ready for deployment, etc.) through a representative marking 1219 on the needle 1210 as described herein or through another marking or tracking mechanism as desired. Needle 1210 may include lines and the housing may include lines that are intended to match or align in order to calibrate needle 1210 to the introduction system 1200 and ensure accurate reliance on depth information that may be understood from representative indicia 1219. Representative mark 1219 may be etched, colored, printed, etc.

In one embodiment, needle 1210 may include an intermediate marker 1222. The intermediate indicia 1222 may be positioned approximately midway of the needle 1210. The intermediate indicia 1222 may be distinguishable from other indicia in one or more of color, shape, length, pattern, etc. For example, as shown in fig. 32, the intermediate mark 1222 may be an elongated black solid mark. For example, the intermediate indicia 1222 may indicate a desired depth of the firing lead 1290 of the needle 1210 in tissue. The intermediate label 1222 may also be used to indicate any other aspect that may be desired.

In one embodiment, needle 1210 may further include a first series of indicia 1225. The first series of indicia 1225 may be positioned between the distal end 1213 of the needle 1210 and the intermediate indicia 1222. The first series of markings 1225 may generally correspond to sequential depths of the needle 1210. For example, the first series of markers 1225 may include markers 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc. The first series of marks 1225 may differ from one another in one or more of color, shape, length, pattern, etc., and from other marks.

For example, as shown in fig. 32, the first mark in the first series of marks 1225 may be a single small line, the second mark may be two small lines, the third mark may be three small lines, and the fourth mark may be four small lines, or the like. The number of lines may indicate the sequential depth of needle 1210, e.g., to the nearest millimeter or centimeter, with a first mark with a single line indicating a depth of 1mm, a second mark with two lines indicating a depth of 2mm, a third mark with three lines indicating a depth of 3mm, a fourth mark with four lines indicating a depth of 4mm, etc. Although the previous examples describe marks representing 1 measurement unit between sequential marks, the number of lines may represent any number of sequential measurement units, such as 2, 5, 10, etc. units between sequential marks. The first indicia may also represent numbers other than one unit, such as 2, 3,4, 5, etc., where the sequential indicia measure an additional one unit for each sequential indicia, etc. It should be noted that a first marker having a single line may be closest to the distal end 1213 of the needle 1210, with the latter markers being evenly spaced apart in sequence toward the intermediate marker 1222 to indicate the depth of the needle 1210. It should also be noted that a first marker having a single line may be closest to the intermediate marker 1222 with the latter markers being evenly spaced apart in sequence toward the distal end 1213 of the needle 1210 to indicate proximity to the intermediate marker 1222.

In one embodiment, needle 1210 may further include a second series of indicia 1228. A second series of indicia 1228 may be positioned between the proximal end 1216 of the needle 1210 and the intermediate indicia 1222. The second series of markings 1228 may generally correspond to sequential depths of the needle 1210. For example, the second series of markers 1228 can include markers 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc. The second series of marks 1228 may differ from one another in one or more of color, shape, length, pattern, etc., and from other marks.

For example, as shown in fig. 32, the first marker in the second series of markers 1228 may be a single small line, the second marker may be two small lines, the third marker may be three small lines, and the fourth marker may be four small lines, etc. The number of lines may indicate the sequential depth of needle 1210, e.g., to the nearest millimeter or centimeter, with a first mark with a single line indicating a depth of 1mm, a second mark with two lines indicating a depth of 2mm, a third mark with three lines indicating a depth of 3mm, a fourth mark with four lines indicating a depth of 4mm, etc. Although the previous examples describe marks representing 1 measurement unit between sequential marks, the number of lines may represent any number of sequential measurement units, such as 2, 5, 10, etc. units between sequential marks. The first indicia may also represent numbers other than one unit, such as 2,3, 4,5, etc., where the sequential indicia measure an additional one unit for each sequential indicia, etc. It should be noted that a first indicia having a single line may be closest to the intermediate indicia 1222 with the latter indicia being evenly spaced in sequence toward the proximal end 1216 of the needle 1210 to indicate the depth of the needle 1210. It should also be noted that a first marker having a single line may be closest to the proximal end 1216 of the needle 1210, with the latter markers being evenly spaced apart in sequence toward the intermediate marker 1222 to indicate proximity to the intermediate marker 1222.

The first series of marks 1225 and the second series of marks 1228 may be distinguished from one another in one or more of color, shape, length, pattern, etc. For example, in fig. 32, the first series of marks 1225 may be black and the second series of marks 1228 may be gray or a different contrasting color or light color. In this embodiment, if a black mark is displayed, this may indicate that the device and needle 1210 are not placed deep enough for lead 1290. As described above, each stripe within the marking may allow a user (e.g., a physician) to know the length of lead 1290 to be implanted to a given depth (e.g., to the nearest millimeter or centimeter).

Fig. 33A-33B illustrate cross-sectional views of an introduction system 1200. The introduction system 1200 may be used with a needle 1210 having a representative label 1222 as shown in fig. 32. For example, needle 1210 may be used as second cannula 1330 as described herein. The introduction system 1200 may be used with any other needle as desired. It should be noted that needle and cannula may be used interchangeably unless the disclosure or context indicates otherwise. In one embodiment, the introduction system 1200 may include a needle 1210, a housing 1230, an actuation mechanism 1250, a lead 1290, and one or more cannulae 1300. In one embodiment, the introduction system 1200 includes two cannulas 1300. In one embodiment, the introduction system 1200 includes three cannulas 1300. In one embodiment, the actuation mechanism 1250 extends and retracts one or more cannulae 1300 to facilitate placement of leads 1290 for electrical stimulation. In one embodiment, lead 1290 can be completely contained within introducer system 1200 until the deployment mechanism is actuated.

The intake system 1200 may include a housing 1230. The housing 1230 may house all or a portion of the actuation mechanism 1250. The housing 1230 may house all or a portion of one or more cannulas 1300. The housing 1230 may include an actuator 1233, see for example the sliding buttons in fig. 34-36, to facilitate transitioning of the lead-in system 1200 and one or more cannulas 1300 from an undeployed position to a deployed position for placement of the lead 1290 (also including one or more transitional positions as described herein). The housing 1230 may generally provide or function as a handle for the introduction system 1200 and may be ergonomically or otherwise formed to be held by a user (e.g., a physician) to place the lead 1290. The housing 1230 may generally include curved portions to generally shape around a human hand and may include one or more pattern portions or portions of different materials to provide a grip for the human hand. The housing 1230 may be formed of any desired material including, but not limited to, plastic, metal, rubber material, and the like. The housing 1230 may be formed by any known process, such as molding, injection molding, extrusion, etc., as desired.

The introduction system 1200 can include a first sleeve 1310. The first sleeve 1310 may include a distal end 1313, a proximal end 1316, and a body 1319. The body 1319 may generally include walls that surround or form a hollow passage. The first sleeve 1310 may be nested or otherwise coupled with other sleeves in the introduction system 1200. In one embodiment, the first sleeve 1310 may be an outer sleeve. In one embodiment, the first sleeve 1310 may be an outermost sleeve. As an outer sleeve, the first sleeve 1310 may house or contain at least one other sleeve. As the outermost sleeve, the first sleeve 1310 may house or contain all other nested sleeves introduced into the system 1200. In one example, the first sleeve 1310 may have a larger diameter or circumference than at least one other sleeve. In one example, the first sleeve 1310 may have a larger diameter or circumference than all other nested sleeves in the introduction system 1200. The first cannula 1310 may have a larger diameter or circumference than the second cannula 1330 and may have a larger diameter or circumference than the third cannula 1350 such that the second cannula 1330 and the third cannula 1350 may nest within the first cannula 1310 (e.g., the second cannula 1330 may nest within the first cannula 1310, the third cannula 1350 may nest within the second cannula 1330).

In one embodiment, the proximal end 1316 of the first sleeve 1310 may be connected or attached to the housing 1230. In one embodiment, the proximal end 1316 of the first sleeve 1310 may terminate at or near the housing 1230, e.g., where the first sleeve 1310 does not extend into the housing 1230 or extends only minimally therein (e.g., through a wall of the housing but not into an internal cavity, etc.). In one embodiment, the first sleeve 1310 may be stationary within the system 1200 through insertion of the system 1200, actuation of the actuation mechanism 1250, and deployment of the lead 1290. In one embodiment, the distal end 1313 and the proximal end 1316 of the first sleeve 1310 may be straight, flat, blunt, or the like. In one embodiment, the first sleeve 1310 may be about 5-25cm, 11cm +/-10cm, or more specifically, for example, 11cm long. In one embodiment, the first sleeve 1310 may have a diameter or circumference of about 0.5-3mm, 1.5mm +/-0.5mm, or more specifically, e.g., 1.5mm, and a thickness of about 0.005-0.1mm, 0.065mm +/-0.05mm, or more specifically, e.g., 0.065 mm. The first sleeve 1310 may be formed of any desired material including, but not limited to, metals (including stainless steel, e.g., 304 stainless steel, 316 stainless steel, etc.) with or without additional coatings, such as parylene or polymers (including PTFE and/or other biocompatible polymers).

The introduction system 1200 may include a second cannula 1330. The second cannula 1330 may include a distal end 1333, a proximal end 1336, and a body 1339. The body 1339 may generally include walls that surround or form a hollow passageway. The second cannula 1330 may be nested or otherwise coupled with other cannulas in the introduction system 1200. In one embodiment, the second cannula 1330 may be an outer cannula. In one embodiment, the second cannula 1330 may be an inner cannula. As an outer sleeve, the second sleeve 1330 may house or contain at least one other sleeve. As an inner cannula, the second cannula 1330 may be inserted into or received by at least one other cannula. In one embodiment, the second cannula 1330 may be a middle cannula in the introduction system 1200 having three nested cannulas. In one example, the second cannula 1330 may have a larger diameter or circumference than at least one other cannula. In one example, the second cannula 1330 may have a smaller diameter or circumference than at least one other cannula. The second cannula 1330 may have a smaller diameter or circumference than the first cannula 1310 and may have a larger diameter or circumference than the third cannula 1350 such that the second cannula 1330 may nest within the first cannula 1310 and the third cannula 1350 may nest within the second cannula 1330.

In one embodiment, the proximal end 1336 of the second cannula 1330 and at least a portion of the body 1339 may extend into and through the housing 1230. In one embodiment, the proximal end 1336 of the second sleeve 1330 may extend into the second channel 1236 of the housing 1230. In one embodiment, during insertion and deployment of lead 1290, second sleeve 1330 can be translated within second channel 1236 by actuation mechanism 1250. In one embodiment, during insertion and deployment of lead 1290, second sleeve 1330 can be translated in a rearward or proximal direction within second channel 1236 by actuation mechanism 1250. In one embodiment, the distal end 1333 and the proximal end 1336 of the second sleeve 1310 may be tapered, angled, pointed, or the like (e.g., as a needle). In one embodiment, the second cannula 1330 may be approximately 5-35cm, 13cm +/-10cm, or more specifically, for example, 13cm long. In one embodiment, the second cannula 1330 may have a diameter or circumference of about 0.3-2.8mm, 1.27mm +/-0.5mm, or more specifically, e.g., 1.27mm, and a thickness of about 0.005-0.1mm, 0.0635mm +/-0.05mm, or more specifically, e.g., 0.0635 mm. The second cannula 1330 may be formed of any desired material, including but not limited to, a metal (including stainless steel, e.g., 304 stainless steel, 316 stainless steel, etc.) with or without an additional coating, such as parylene or a polymer (including PTFE and/or other biocompatible polymers).

The introduction system 1200 may include a third cannula 1350. The third cannula 1350 may include a distal end 1353, a proximal end 1356, and a body 1359. The body 1359 may generally include walls surrounding or forming a hollow channel. The third cannula 1350 may be nested or otherwise coupled with other cannulas in the introduction system 1200. In one embodiment, the third cannula 1350 may be an inner cannula. In one embodiment, the third cannula 1350 may be the innermost cannula. As the inner cannula, the third cannula 1350 may be inserted into or received by at least one other cannula. As the innermost cannula, the third cannula 1350 may be inserted into or received by all other nested cannulas in the introduction system 1200. In one example, the third cannula 1350 can have a smaller diameter or circumference than at least one other cannula. In one example, the third sleeve 1310 may have a smaller diameter or circumference than all other nested sleeves in the introduction system 1200. The third cannula 1350 may have a smaller diameter or circumference than the second cannula 1330 and may have a smaller diameter or circumference than the first cannula 1310 such that the third cannula 1350 may nest within the second cannula 1330 and the first cannula 1310 (e.g., the third cannula 1350 may nest within the second cannula 1330 and the second cannula 1330 may nest within the first cannula 1310).

In one embodiment, the proximal end 1356 of the third cannula 1350 and at least a portion of the body 1359 may extend into and through the housing 1230. In one embodiment, the proximal end 1356 of the third cannula 1350 may extend into the second passage 1236 of the housing 1230 and into the third passage 1239 of the housing 1230. In one embodiment, during insertion and deployment of lead 1290, third sleeve 1350 can be translated within second channel 1236 and third channel 1239 by actuation mechanism 1250. In one embodiment, during insertion and deployment of lead 1290, third cannula 1350 can be translated by actuation mechanism 1250 in a rearward or proximal direction and in a forward or distal direction within second channel 1236 and third channel 1239. In one embodiment, the distal end 1313 and the proximal end 1316 of the third cannula 1350 may be straight, flat, blunt, or the like. In one embodiment, the third sleeve 1350 may be approximately 5-50cm, 19cm +/-10cm, or more specifically, for example, 19cm long. In one embodiment, the third sleeve 1350 may have a diameter or circumference of about 0.1-2.6mm, 0.9mm +/-0.5mm, or more specifically, e.g., 0.9mm, and a thickness of about 0.005-0.1mm, 0.0575mm +/-0.05mm, or more specifically, e.g., 0.0575 mm. The third cannula 1350 may be formed of any desired material including, but not limited to, metals (including stainless steel, e.g., 304 stainless steel, 316 stainless steel, etc.) with or without additional coatings, such as parylene or polymers (including PTFE and/or other biocompatible polymers).

Fig. 37 illustrates various positions of the foremost or distal portion of an embodiment of an introduction system 1200, including various positions of the first cannula 1310, the second cannula 1330, and the third cannula 1350 during deployment of the lead 1290. The smallest third cannula 1350 may be configured to nest within the second cannula 1330, which in turn may be configured to nest within the largest first cannula 1310. As shown in fig. 27, the cannulas 1310, 1330, 1350 may desirably be capable of being arranged in multiple stages. Exemplary phases may include phase a, wherein lead 1290 is fully contained within sleeves 1310, 1330, 1350, allowing introduction system 1200 to be inserted and reoriented as needed, phase B, wherein lead 1290 is advanced such that the distal-most portion 1292 of lead 1290 matches the position of tip 1333 of sleeve or introducer needle 1330, phase C, wherein lead 1290 remains at a target position or distance while sleeves 1350, 1330 are withdrawn (desirably within the outermost stationary sleeve 1310); and stage D, in which lead 1290 is deployed indwelling at the desired location.

As shown in stage a of fig. 33A, a portion of the second cannula 1330 may extend from the distal end 1313 of the first cannula 1310 in an undeployed position. The third cannula 1350 may include a lead 1290 therein, wherein only the anchor 1293 on the distal end 1292 of the anchor 1293 extends or is exposed from the distal end 1353 of the third cannula 1350. Third sleeve 1350 and nested lead 1290 may be nested within second sleeve 1330 and first sleeve 1310 such that neither third sleeve 1350 nor lead 1290 is exposed to introduction system 1200, but is entirely contained within introduction system 1200.

In the transitional position shown in stage B of fig. 33A, the third cannula 1350 and the nested lead 1290 can extend to, near, before, or after the distal end 1333 of the second cannula 1330. Because the distal end 1333 of the second cannula 1330 may be tapered, angled, pointed, or the like (e.g., as a needle), the third cannula 1350 and the nested lead 1290 may both be exposed from the second cannula 1330 (e.g., on a shorter side of the distal end 1333 of the second cannula 1330), and the third cannula 1350 and the nested lead 1290 may be positioned approximately equal to the distal end 1333 of the second cannula 1330 (e.g., on a longer side of the distal end 1333 of the second cannula 1330)

In the transitional position shown in stage C of fig. 33A, lead 1290 may remain in position in stage B and third sleeve 1350 and second sleeve 1330 may be withdrawn from lead 1290. In one embodiment, third cannula 1350 and second cannula 1330 may be withdrawn from lead 1290 simultaneously as a unit, e.g., as third cannula 1350 and second cannula 1330 are withdrawn simultaneously and at the same speed and into first cannula 1310, they remain in position relative to each other. In one embodiment, the third cannula 1350 and the second cannula 1330 may be sequentially withdrawn from the lead 1290, e.g., the third cannula 1350 is first withdrawn into the second cannula 1330, then the second cannula 1330 (with the third cannula 1350 nested therein) is withdrawn into the first cannula 1310, or vice versa. In one embodiment, the third cannula 1350 may be fully retracted into the second cannula 1330, or the third cannula 1350 may remain partially extended from the second cannula 1330. In one embodiment, the second cannula 1330 and the third cannula 1350 may be fully retracted into the first cannula 1310 (see, e.g., fig. 33B, sequence four), or the second cannula 1330 and the third cannula 1350 may remain partially extended from the first cannula 1310 (see, e.g., fig. 37, sequence C).

As shown in stage D of fig. 33A, all of the cannulae, e.g., first cannula 1310, second cannula 1330, and third cannula 1350, may be withdrawn from lead 1290 such that only lead 1290 remains. It should be noted that the distal end of the introduction system 1200 in each of stages a-D, including the distal end 1333 of the second cannula 1330 in stage a, the distal ends 1333, 1353, 1292 of the second cannula 1330, third cannula 1350 and lead 1290, respectively, in stage B, and the distal end 1292 of the lead 1290 in stages C and D, may be inserted into tissue in order to accurately place the lead 1290 at a desired location or region of tissue.

The introduction system 1200 can include an actuation mechanism 1250. Various embodiments of the actuation mechanism 1250 are shown in the figures, including figures 33A-33B, 35, 39, 40A-40B, 41, 42, 44A-44D, and so forth. Actuation mechanism 1250 may facilitate actuation and deployment of lead 1290 and transition between an undeployed position in which lead 1290 is disposed and a deployed position (also including one or more transitional positions as described herein). The actuation mechanism 1250 may generally be contained or housed within the housing 1230 and may include an actuator 1233 that moves one or more of the cannulas 1320, 1330, 1350.

For example, fig. 33A-33B illustrate movement of components (e.g., cannulae 1310, 1330, 1350) relative to one another to achieve a result (e.g., placement and deployment of lead 1290). The system shown in fig. 33A-33B may be used with any of the actuation mechanisms 1250 described herein, and may include springs or other biasing members, slides, ramps, screws, and the like. As shown in fig. 33A-33B, for example, the system 1200 or the actuation mechanism 1250 may include a first stopping point 1253 and a second stopping point 1256. The actuation mechanism 1250 may include components that move and stop relative to each other in order to accomplish multiple actions using biasing members or the like. Fig. 33A illustrates an embodiment in which the lead 1290 remains a fixed length, while fig. 33B illustrates an embodiment in which a portion of the lead 1290 remains compressed and relaxed as the lead anchor 1293 is advanced to the distal end 1333 of the second sleeve 1330 (e.g., the tip of a needle).

The two embodiments depicted in fig. 33A and 33B variously achieve the ability to maintain the position of the lead 1290 at a target position in tissue during withdrawal of the second cannula 1330 and the third cannula 1350 by providing a stop for the proximal end of the lead 1290 during retraction of the second cannula 1330 and the third cannula 1350. Without such a mechanism, friction of the lead 1290 body within the third cannula 1350 and/or the lead anchor 1293 within the second cannula 1330 and/or the third cannula 1350 may result in the lead 1290 being pulled back from the target position rather than remaining in the desired position (e.g., matching the forward-most position or tip of the second cannula 1330 prior to actuation of the deployment mechanism 1250).

Fig. 33A illustrates that positioning of the stop may be achieved through a third channel, which in one example may be formed by a hypotube or other method of forming a lumen, which may be advanced with the third cannula 1350 upon actuation of the lead deployment mechanism 1250 and then locked in an anterior position to provide a fixed stop during withdrawal of the second cannula 1330 and the third cannula 1350.

Fig. 33B illustrates that the positioning of the stop may be implemented such that it remains stationary during lead deployment, but before lead deployment begins, the necessary actions are accomplished by compressing the proximal portion of lead 1290 and maintaining its compression during storage and initial use of system 1200.

This retention of the proximal portion of lead 1290 in a compressed state can be accomplished in a variety of ways, including an embodiment wherein one or more bushings or housing members can have windows, slots, or other openings through which a mechanism (such as a pin, living hinge, stop, or other mechanism, see mechanism 1251, e.g., using a living hinge as shown in fig. 45) can retain the position of lead 1290 and prevent a compressive force placed on the proximal portion of lead 1290 from pushing lead 1290 forward prior to deployment of lead 1290. Such a mechanism may be released upon actuation of the lead deployment mechanism 1250 such that the lead 1290 can then be advanced appropriately with the third cannula 1350. Such a securing mechanism may also advantageously help retain lead 1290 within third sleeve 1350 and second sleeve 1330 during transportation, storage, and operation of system 1200 prior to actuation of the lead deployment mechanism.

It should be noted that fig. 45B includes the components of fig. 45A, but flipped in another direction, and shows the living hinge bent to its possible position for capturing and holding lead 1290.

The first stop 1253 may be positioned in the housing 1230 and may be located on the second sleeve 1330. The first stop 1253 may limit the length that the second sleeve 1330 may extend out of the housing 1230. The second stop 1256 may be positioned in the housing 1230 and may be located on the third sleeve 1350. The second stopping point 1256 may be translated within the second passage 1236 and the third passage 1239 of the housing 1240. The second stop point 1256 may stop and engage with the second sleeve 1330 within the housing 1230, which in turn may push the second stop point 1256 and the third sleeve 1350 within the housing.

In one embodiment, lead 1290 may be fully contained within introducer system 1200 and within one or more cannulas (e.g., second cannula 1330) until deployment or actuation mechanism 1250 is actuated. In one example, the actuation mechanism 1250 may be actuated by an actuator 1233. The actuator 1233 may be a sliding or sliding actuation mechanism as shown in fig. 34-36 and 41-44A-44D, the actuator 1233 may be an angled button as shown in fig. 39, the actuator 1233 may be a rotating shaft as shown in fig. 40A-40C, or the actuator 1233 may be any other mechanism desired. As described herein, in one embodiment, the first or largest nested cannula (e.g., first cannula 1310) may be fixed and may not move in a forward or backward direction relative to other components of the introduction system 1200 (excluding movement of a user of the entire introduction system 1200). In one embodiment, the second cannula or intermediate nested cannula (e.g., second cannula 1330) may move in a rearward direction, and in one embodiment may not move in a forward direction relative to other components of the introduction system 1200 (excluding movement of a user of the entire introduction system 1200). In one embodiment, the third cannula or the smallest nested cannula (e.g., third cannula 1350) may be moved in a forward and rearward direction relative to other components of the introduction system 1200 (excluding movement of a user of the entire introduction system 1200).

For example, the introduction system 1200 and the intermediate cannula (e.g., 1330) may be specifically inserted as a needle into the skin or tissue of a person or patient at a desired location. The innermost sleeve (e.g., 1350) can be moved forward exposing lead 1290 and its anchor 1293 to attach to tissue at a desired location. The intermediate sleeve (e.g., 1330) can then be retracted to further expose lead 1290 and its anchor 1293 for attachment to tissue at a desired location. The innermost sleeve (e.g., 1350) and, in some embodiments, the middle sleeve (e.g., 1330) together may then be moved back to retract and allow lead 1290 to remain in place. The introducer system 1200 may then be withdrawn further from the lead 1290 as a unit. Referring also to, for example, fig. 37-38 and other figures, methods and uses of the introduction system 1200 and placement of the lead 1290 using a multi-cannula mechanism are shown and described.

Such devices and methods may allow for precise positioning and placement of lead 1290, where accuracy may be critical to providing electrical stimulation at the lead 1290 placement site. The multi-sleeve system may prevent lead 1290 and anchor 1293 of lead 1290 from seizing within the system, but may provide a protective sheath that facilitates direct movement and placement of lead 1290.

For example, fig. 34-36 illustrate an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a sliding actuation mechanism 1233 can be used to actuate a desired advancement of a third cannula 1350 and a lead 1290 and a subsequent retraction of a second cannula 1330 and third cannula 1350 such that the lead 1290 remains in the forward/deployed position.

For example, fig. 39 illustrates an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a compression or pushing mechanism 1233 can be used to actuate the desired advancement of the third cannula 1350 and the lead 1290 and the subsequent retraction of the second cannula 1330 and the third cannula 1350 such that the lead 1290 remains in the advanced/deployed position.

For example, fig. 40A-40C illustrate an embodiment of an introduction system 1200 and an actuation mechanism 1250 that utilizes a rotation mechanism 1233 that can actuate a desired advancement of a third cannula 1350 and a lead 1290 and a subsequent retraction of a second cannula 1330 and third cannula 1350 such that the lead 1290 remains in the forward/deployed position.

For example, fig. 41 illustrates an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a sliding actuation mechanism 1233 can be used with a barrel cam mechanism to achieve and actuate a desired advancement of the third cannula 1350 and lead 1290 and a subsequent retraction of the second cannula 1330 and third cannula 1350 such that the lead 1290 remains in the advanced/deployed position. For example, the number of the cells to be processed,

Fig. 42 illustrates an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a sliding actuation mechanism 1233 utilizes a compressive force on a proximal portion of the lead 1290 to ensure that the lead 1290 remains in a desired forward position and does not pull back with the retracted second and third cannulas 1330, 1350 when the deployment mechanism is actuated.

For example, fig. 43 illustrates an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a sliding actuation mechanism 1233 can be used to actuate the desired advancement of the third cannula 1350 and lead 1290 and the subsequent retraction of the second cannula 1330 and third cannula 1350 such that the lead 1290 remains in the forward/deployed position. The housing 1230 of the introduction system 1200 in fig. 43 further includes one or more gripping portions to facilitate the user's gripping and use of the introduction system 1200 to deploy and place the lead 1290.

For example, fig. 44A-44D illustrate an embodiment of an introduction system 1200 and an actuation mechanism 1250 in which a sliding actuation mechanism 1233 can be used to actuate a desired advancement of a third cannula 1350 and a lead 1290 and a subsequent retraction of a second cannula 1330 and third cannula 1350 such that the lead 1290 remains in the forward/deployed position. In one embodiment, the sliding actuation mechanism 1233 or lever may interact with a rotating mechanism with an integrated cam that actuates a number of other mechanisms that provide the functionality of the introduction system 1200.

These mechanisms may include: a living hinge that holds lead 1290 in place and prevents lead 1290 from falling out of the rear end; a plunger mechanism desirably holding a loaded (e.g., biased by a spring or the like) lead 1290 in place to prevent unwanted movement, e.g., during shipping, handling, insertion, etc.; a safety mechanism that prevents the trigger/slide/actuation mechanism 1233 from being actuated until needed; a mechanism that moves lead 1290 and the lead containment tube (e.g., third sleeve 1350) forward upon actuation of the slide mechanism 1250 and subsequent rotation of the rotation mechanism; a mechanism that releases lead 1290 as lead 1290 advances so that it is no longer constrained within the assembly (e.g., within third sleeve 1350 and other components) by the plunger mechanism; one or more spring mechanisms that are actuated to retract the desired sleeves 1310, 1330, 1350 to leave the lead 1290 in place when the lead 1290 is fully advanced to the desired position; a stop mechanism that advances with lead 1290 during advancement but remains in place and prevents retraction of lead 1290 when sleeves 1310, 1330, 1350 are retracted; and an electrical contact mechanism that allows the delivery of test stimulus through the cannulas 1310, 1330, 1350, but can also be disconnected upon deployment of the lead 1290 so that no unintended electrical stimulus occurs. The actuation mechanism 1250 may further include a "rack and pinion" in which a moving component or "sled" drives the "pinion" that is deployed. These 4 pictures are snapshots of the mechanism moving over time.

Fig. 38 illustrates an embodiment of a process 1400 for using the intake system 1200. In one embodiment, the lead-in system 1200 illustrates how the process 1400 may minimize the number of steps required in a typical lead deployment system. For example, to deploy the lead 1290, a typical process 1491 may generally include multiple steps, such as the eight steps shown in fig. 38. The described lead-in system 1200 can simplify the process and desirably requires a minimum number of steps 1410, 1420, 1430, 1440, such as the four steps shown in fig. 38, to allow placement, testing of the stimulus and deployment of the lead 1290 at the target location. For example, at step 1410, the user may place and target a nerve using the lead-in system 1200, at step 1420 the user may connect and test the stimulus, at step 1430 the user may use the actuator 1233 to actuate the actuation mechanism 1250 (e.g., also as the cannulas 1330, 1350 are extended and retracted to deploy the lead 1290), and at step 1440 the user may withdraw the lead-in system 1200, leaving the lead 1290 inserted to the desired target location.

The electrical stimulation leads may be placed percutaneously to target the peripheral nerve such that the leads take disjoint paths in the vicinity of the nerve. This approach maintains an optimal (e.g., minimum) distance between the lead and the nerve when the trajectory of the nerve brings the lead and the nerve closest. By maintaining a minimum distance (e.g., 0.1cm-5.0cm, 0.5cm-3.0 cm), the safety of the procedure is improved by reducing the risk of the lead and/or needle placement of the lead in contact with or penetrating the nerve. Holding the lead away from the nerve also facilitates selective stimulation of large diameter (target) fibers relative to small diameter (non-target) fibers—an example is disclosed in U.S. patent No.8,788,046, incorporated herein by reference. Existing methods of placing percutaneous nerve stimulation leads include directing the leads directly toward the nerve, which increases the risk of nerve penetration and reduces the chance of effective stimulation by enabling placement of the leads close to the nerve. In contrast, the present method overcomes these limitations by introducing electrical stimulation leads on disjoint trajectories such that the leads will be near or next to (medial or lateral to), above (surface) or below (deep) the nerve, rather than near the minimum distance of the nerve (e.g., 0.1cm-5.0 cm). The non-intersecting method may be perpendicular to the nerve (e.g., a cross-section or an axial cross-section near the nerve), parallel to the nerve, or at some other non-orthogonal (non-perpendicular) angle to the nerve.

Prior to the present invention, the use of disjoint methods and/or trajectories was considered counterintuitive for several reasons. Previously, existing methods and means used intersecting (e.g., intersecting all or part of the nerve on the target if the needle, lead, and/or electrode were sufficiently advanced) and/or nearly intersecting trajectories such that the lead and/or electrode would be placed adjacent, touching, contacting, and/or nearly adjacent to the nerve (e.g., as close to intersecting as possible, and/or practical). The previously thought intersecting and/or nearly intersecting methods provide the greatest ability to optimize lead placement relative to activation of target nerve fibers within the nerve. However, the present invention includes a new approach that does not intersect the (nerve) and provides increased potential efficacy (e.g., benefits to the patient such as increased activation of the target pain relieving fiber and/or increased pain relief) and increased safety (e.g., reduced safety risk to the patient).

The non-intersecting (e.g., "fly-through") method of the present invention also enables test stimulation of both sides of the nerve trunk as the leads move from one side of the nerve trunk to the other (e.g., right to left, left to right, inside to outside, outside to inside, top to bottom, bottom to top, front to back, back to front). For example, the lead may be inserted from the side of the nerve and the stimulation may be tested as the electrode is closer to the inside of the nerve than the outside. Stimulation may also be tested when the lead is directly above the nerve, and when the electrode is closer to the inside of the nerve than the outside. This allows the user to determine whether one side of the stimulating nerve is preferred over the other side of the stimulating nerve (e.g., providing better pain relief, producing more complete coverage of the pain area with a pleasant sensation, producing greater muscle contraction at the preferred target area). Existing methods of directing leads directly to the nerve (e.g., a trajectory intersecting the nerve) do not allow for stimulation of both sides of the nerve, as the nerve will puncture and damage the nerve before reaching the other side.

Another approach is to place the lead such that the length of the stimulation electrode faces the target nerve. One way to achieve this is to guide the lead along a path that passes through the nerve but does not intersect the nerve. This approach exposes the nerve trunk to a wider, more uniform current distribution, which may improve the desired stimulation effect (e.g., greater pain relief, pain relief for more pain areas, selective stimulation of small diameter fibers by large diameter fibers, greater coverage of all pain areas). In addition, this approach can better activate both sides of the nerve (e.g., right and left, top and bottom, medial and lateral, superior and inferior) simultaneously. Existing methods of stimulating electrodes directed toward the nerve (e.g., exposing less electrode surface area to the nerve) reduce the ability to provide more spatially uniform nerve fiber activation within the torso, which reduces therapeutic benefit and increases the likelihood of discomfort (e.g., unwanted sensation, muscle contraction). Existing methods, such as those in which the electrical stimulation leads are directed toward the target nerve, may result in a small profile of the nerve-facing stimulation surface of the electrode, such as a profile similar to a point source when the profile is considered from a nerve perspective (e.g., when viewed along a straight line between the nerve and the stimulation electrode leads). The disclosed method improves upon prior methods by inserting or inserting stimulation electrodes along a trajectory to a location that maximizes or increases the effective stimulation surface, presenting a larger stimulation surface profile than prior methods.

In a non-limiting example, the lead may be placed at a location around the peripheral nerve that does not contain muscle and allows sufficient space (e.g., >1mm or >3-5 mm) to place the electrode at a location away from the nerve (e.g., >1mm or >3-5 mm). The space around the nerve may be filled with adipose tissue, connective tissue, fluid, or other non-muscle tissue. The space may be located between muscles (e.g., separated by fascia layers), between muscles and bones, within a hole, within a neurovascular bundle (sheath), or between/within other structures of the body. By avoiding placement of the electrodes in the muscles, the chance of unwanted muscle contraction around the electrodes is reduced and the ability to comfortably create pain relief is increased. For example, the femoral nerve can be targeted by placing a lead in the space between the fascia lata and ilium below the inguinal (thigh) folds. This placement avoids implantation of the electrodes into the surrounding muscles, which minimizes the chances of muscle contraction that limits the maximum stimulation intensity that the patient can tolerate (and thus may limit the potential therapeutic benefit). As another example, the sciatic nerve may be targeted by placing the lead in the space around the sciatic nerve or in the sciatic foramen just deep (i.e., ventral/anterior) in the piriformis of the upper buttock. In this space, the leads may be placed outside, inside, ventral or posterior of the sciatic nerve, and the available space around the nerve varies from patient to patient. The sciatic nerve may also be targeted by placing the lead at other locations (e.g., through under the piriformis of the gluteus maximus, under the gluteus maximus, or between the gluteus maximus and sciatic nerve bifurcation). As another non-limiting example, nerves of an arm (e.g., median nerve, ulnar nerve, radial nerve, musculodermal nerve) may be targeted by placing a lead in a space defined by bicep, tricep, brachial and/or humerus that does not contain muscle tissue but peripheral nerves, blood vessels and other tissue (e.g., fat, connective tissue).

The electrical stimulation lead may include a filament electrode, paddle electrode, intramuscular electrode, cylindrical lead (e.g., with one or more electrodes and/or contacts), or a universal electrode that is inserted via a needle introducer or surgically implanted near the target peripheral nerve. If a needle introducer is used, the needle introducer may be withdrawn after placement of the lead, leaving the electrode in place. Stimulation may also be applied by penetrating the electrodes, such as an electrode array consisting of any number (i.e., one or more) of needle electrodes that may be inserted into the target site. In both cases, the lead may be placed using a needle introducer, allowing for minimally invasive placement of the lead/electrode. In representative embodiments, the leads may include thin flexible components made of metal and/or polymeric materials. By "thin" is meant that the wire has a diameter of no greater than about 0.75mm (0.030 inch). However, the present teachings are not limited to such dimensions. Any suitable lead may be used.

The leads may include one or more coil-like metal wires within an open or flexible elastomeric core. The leads may be insulated, for example, with a biocompatible polymer film such as a polyfluorocarbon, polyimide, or parylene. The lead may be electrically insulated anywhere except for, for example, one (monopolar), two (bipolar) or three (tripolar) conducting locations near its distal tip.

Each of the conductive locations may be connected to one or more conductors, which may extend the length of the lead or a portion thereof. The conductive locations or electrodes may include uninsulated regions of insulated conductors that may extend the length of the entire insulated electrode or a portion thereof. The uninsulated conductive region of the conductor may be formed differently, e.g., it may be wound at a different pitch, or wound at a larger or smaller diameter, or molded to different dimensions. The conductive sites or electrodes may comprise a separate material (e.g., metal or conductive polymer) that is exposed to the body tissue to which the conductors of the leads are bonded. The uninsulated region of the electrode may form a stimulation surface of the electrode, and the combination of one or more uninsulated regions may determine a profile of the stimulation surface relative to the target nerve.

The leads may have mechanical properties in terms of flexibility and fatigue life, taking into account the dynamic properties of the surrounding tissue (i.e., stretching, bending, pushing, pulling, squeezing, etc.), thereby providing an operational life free of mechanical and/or electrical failure. In a non-limiting example, the lead may be placed in non-muscle tissue, such as in the upper arm near an arm nerve (e.g., median nerve, ulnar nerve, radial nerve, musculodermal nerve) in the space defined by bicep, tricep, humerus, and/or humerus, such that bending of the arm may result in bending of the lead.

Embodiments of the lead may include a minimally invasive coil-like thin wire lead and an electrode. The electrode may also include an anchor element at its distal tip. The anchoring element may take the form of a simple barb or bend. The anchoring element may be sized and shaped such that when in contact with tissue, the anchoring element enters the tissue to prevent the electrode from moving or migrating out of the correct position in the surrounding tissue. The anchoring element itself may be or be continuous with the uninsulated conductive region of the lead such that the stimulation surface area or profile of the stimulation surface area relative to the target nerve is determined in part or in whole by the orientation of the anchoring element relative to the target nerve.

The leads may also be designed and manufactured to present electrode geometry, shape, and/or size to maximize the benefits of the present invention (e.g., as part of a peripheral nerve stimulation system, which may be percutaneous and/or fully implantable).

It should be noted that any descriptions relating to the various embodiments described herein, such as, but not limited to, systems 2000, 100, 1000, 1200, etc., and components associated therewith, may be isolated and adapted to each other, such as, for example, systems 2000, 100, 1000, 1200, etc., and components associated therewith.

What has been described above includes examples of the present specification. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present specification, but one of ordinary skill in the art may recognize that many further combinations and permutations of the present specification are possible. Each of the above components may be combined or added together in any arrangement to define an introducer system. Accordingly, the specification is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.

Claims

1. A lead introducer system, comprising:

A housing;

an outer sheath fixed relative to the housing;

An inner sheath configured to hold a lead, the inner sheath positioned in and movable relative to the intermediate sheath and the outer sheath;

An actuator in biased engagement with the intermediate sheath and the inner sheath, wherein upon actuation, the inner sheath and lead are deployed into tissue.

2. The lead introducer system of claim 1 wherein the inner sheath and the lead are movable in a distal direction upon actuation.

3. The lead introducer system of claim 2 wherein upon actuation, the inner sheath and the intermediate sheath are retractable in a proximal direction.

4. The lead introducer system of claim 3 wherein movement of the inner sheath and the lead in the distal direction and retraction of the inner sheath and the intermediate sheath occur sequentially.

5. The lead introducer system of claim 3 wherein retraction of the inner sheath and the intermediate sheath occurs automatically after movement of the inner sheath and the lead in the distal direction.

6. The lead introducer system of any of claims 1-5, wherein the lead is configured to anchor in tissue when moved in a distal direction and remain positioned in an accurate position when the inner sheath and the intermediate sheath are withdrawn.

7. The lead introducer system of any of claims 1-6, wherein the housing comprises one or more handles.

8. The lead introducer system of any of claims 1-7 wherein the lead introducer system is operable using one hand.

9. A lead introducer system, comprising:

a housing configured to be held by a single hand of a user;

an outer sheath fixed relative to the housing;

an actuator in biased engagement with the inner sheath, wherein upon actuation of the actuator, the inner sheath moves toward and away from a target tissue region.

10. The lead introducer system of claim 9, further comprising an intermediate sheath, wherein the inner sheath is nestable within the intermediate sheath and the intermediate sheath is nestable within the outer sheath.

11. The lead introducer system of claim 10 wherein the inner sheath and the lead are movable together in a distal direction upon actuation.

12. The lead introducer system of claim 11 wherein the inner sheath and the intermediate sheath are retractable together in a proximal direction after actuation.

13. The lead introducer system of any one of claims 8-12 further comprising a test electrode insertable into the target tissue region, wherein the lead is positionable at an accurate location of the test electrode by actuation of the introducer system.

14. The lead introducer system of any one of claims 8-13, wherein actuation of the lead introducer system includes deploying the inner sheath and the lead into the target tissue region, anchoring the lead into the target tissue region, and automatically withdrawing the inner sheath from the anchored lead in a single actuation.

15. The lead introducer system of any of claims 8-14 wherein the actuator is a sliding button.